Heart Failure With Reduced Ejection Fraction Clinical Trial
— PARADIGM-HFOfficial title:
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).
Status | Completed |
Enrollment | 8442 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must give written informed consent before any assessment is performed. - Outpatients = 18 years of age, male or female. - Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =< 35%) and elevated BNP. - Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks. - Patients must be treated with a ß-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks. Exclusion Criteria: - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. - History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs. - Previous history of intolerance to recommended target doses of ACEIs or ARBs - Known history of angioedema. - Requirement of treatment with both ACEIs and ARBs. - Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy). - Symptomatic hypotension and/or a SBP < 100 mmHg. - Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula - Serum potassium > 5.2 mmol/L. Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Argentina | Novartis Investigative Site | Buenos Aires | San Juan |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Buenos Aires | |
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Argentina | Novartis Investigative Site | Caba | Buenos Aires |
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Argentina | Novartis Investigative Site | Ciudad Autonoma de Bs As | Buenos Aires |
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India | Novartis Investigative Site | Nashik | Maharashtra |
India | Novartis Investigative Site | Nashik | Maharashtra |
India | Novartis Investigative Site | Pune | Maharashtra |
India | Novartis Investigative Site | Pune | Maharashtra |
India | Novartis Investigative Site | Pune | Maharashtra |
India | Novartis Investigative Site | Rajkot | Gujrat |
India | Novartis Investigative Site | Surat | Gujarat |
India | Novartis Investigative Site | Tirupati | Andhra Pradesh |
India | Novartis Investigative Site | Trivandrum | Kerala |
India | Novartis Investigative Site | Trivandrum | Kerala |
India | Novartis Investigative Site | Vadodara | Gujrat |
India | Novartis Investigative Site | Varanasi | Uttar Pradesh |
India | Novartis Investigative Site | Vishakhapatnam | Andhra Pradesh |
India | Novartis Investigative Site | Vishakhapatnam | Andhra Pradesh |
Israel | Novartis Investigative Site | Ashkelon | |
Israel | Novartis Investigative Site | Hadera | |
Israel | Novartis Investigative Site | Haifa | |
Israel | Novartis Investigative Site | Haifa | |
Israel | Novartis Investigative Site | Jerusalem | |
Israel | Novartis Investigative Site | Jerusalem | |
Israel | Novartis Investigative Site | Petach Tikva | |
Israel | Novartis Investigative Site | Rehovot | |
Israel | Novartis Investigative Site | Safed | |
Italy | Novartis Investigative Site | Albano Laziale | RM |
Italy | Novartis Investigative Site | Aosta | AO |
Italy | Novartis Investigative Site | Battipaglia | SA |
Italy | Novartis Investigative Site | Bergamo | BG |
Italy | Novartis Investigative Site | Bolzano | BZ |
Italy | Novartis Investigative Site | Casorate Primo | PV |
Italy | Novartis Investigative Site | Catanzaro | CZ |
Italy | Novartis Investigative Site | Cava De' Tirreni | SA |
Italy | Novartis Investigative Site | Cona | FE |
Italy | Novartis Investigative Site | Cortona | AR |
Italy | Novartis Investigative Site | Cosenza | CS |
Italy | Novartis Investigative Site | Firenze | FI |
Italy | Novartis Investigative Site | Genova | GE |
Italy | Novartis Investigative Site | Lido di Camaiore | LU |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Milazzo | ME |
Italy | Novartis Investigative Site | Modena | MO |
Italy | Novartis Investigative Site | Monza | MB |
Italy | Novartis Investigative Site | Palmanova | UD |
Italy | Novartis Investigative Site | Pavia | PV |
Italy | Novartis Investigative Site | Perugia | PG |
Italy | Novartis Investigative Site | Pescia | PT |
Italy | Novartis Investigative Site | Piove di Sacco | PD |
Italy | Novartis Investigative Site | Pisa | PI |
Italy | Novartis Investigative Site | Pozzilli | IS |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | Salerno | SA |
Italy | Novartis Investigative Site | San Daniele Del Friuli | UD |
Italy | Novartis Investigative Site | San Pietro Vernotico | BR |
Italy | Novartis Investigative Site | Sassari | SS |
Italy | Novartis Investigative Site | Seriate | BG |
Italy | Novartis Investigative Site | Stradella | PV |
Italy | Novartis Investigative Site | Thiesi | SS |
Italy | Novartis Investigative Site | Tradate | VA |
Italy | Novartis Investigative Site | Treviglio | BG |
Italy | Novartis Investigative Site | Varese | VA |
Italy | Novartis Investigative Site | Vibo Valentia | VV |
Korea, Republic of | Novartis Investigative Site | Busan | |
Korea, Republic of | Novartis Investigative Site | Daegu | |
Korea, Republic of | Novartis Investigative Site | Daegu | |
Korea, Republic of | Novartis Investigative Site | Gwangju | |
Korea, Republic of | Novartis Investigative Site | Pusan | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Suwon | Gyeonggi-do |
Korea, Republic of | Novartis Investigative Site | Wonju | Gangwon-Do |
Latvia | Novartis Investigative Site | Daugavplis | |
Latvia | Novartis Investigative Site | Kuldiga | |
Latvia | Novartis Investigative Site | Liepaja | LV |
Latvia | Novartis Investigative Site | Preili | |
Latvia | Novartis Investigative Site | Riga | |
Latvia | Novartis Investigative Site | Ventspils | |
Lithuania | Novartis Investigative Site | Kaunas | |
Lithuania | Novartis Investigative Site | Kaunas | |
Lithuania | Novartis Investigative Site | Kedainiai | |
Lithuania | Novartis Investigative Site | Siauliai | |
Lithuania | Novartis Investigative Site | Vilnius | |
Malaysia | Novartis Investigative Site | Kuala Lumpur | |
Malaysia | Novartis Investigative Site | Kuala Lumpur | |
Malaysia | Novartis Investigative Site | Kuching | Sarawak |
Malaysia | Novartis Investigative Site | Pulau Pinang | Penang |
Mexico | Novartis Investigative Site | Aguascalientes | |
Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
Mexico | Novartis Investigative Site | Mexico | Distrito Federal |
Mexico | Novartis Investigative Site | México | Distrito Federal |
Mexico | Novartis Investigative Site | Mexico City | Distrito Federal |
Mexico | Novartis Investigative Site | Mexico D.F | Distrito Federal |
Mexico | Novartis Investigative Site | Monterrey | Nuevo León |
Mexico | Novartis Investigative Site | Queretaro | |
Mexico | Novartis Investigative Site | San Juan del Rio | Queretaro |
Mexico | Novartis Investigative Site | San Luis Potosi | |
Mexico | Novartis Investigative Site | San Luis Potosí | |
Mexico | Novartis Investigative Site | San Luis Potosí | |
Mexico | Novartis Investigative Site | Zapopan | Jalisco |
Netherlands | Novartis Investigative Site | Amersfoort | |
Netherlands | Novartis Investigative Site | Arnhem | |
Netherlands | Novartis Investigative Site | Blaricum | |
Netherlands | Novartis Investigative Site | Breda | |
Netherlands | Novartis Investigative Site | Delft | |
Netherlands | Novartis Investigative Site | Den Bosch | |
Netherlands | Novartis Investigative Site | Den Haag | |
Netherlands | Novartis Investigative Site | Ede | |
Netherlands | Novartis Investigative Site | Eindhoven | |
Netherlands | Novartis Investigative Site | Goes | |
Netherlands | Novartis Investigative Site | Gorinchem | |
Netherlands | Novartis Investigative Site | Hardenberg | |
Netherlands | Novartis Investigative Site | Harderwijk | |
Netherlands | Novartis Investigative Site | Heerenveen | |
Netherlands | Novartis Investigative Site | Hengelo | |
Netherlands | Novartis Investigative Site | Hoorn | |
Netherlands | Novartis Investigative Site | Maastricht | |
Netherlands | Novartis Investigative Site | Nijmegen | |
Netherlands | Novartis Investigative Site | Oss | NL |
Netherlands | Novartis Investigative Site | Sneek | |
Netherlands | Novartis Investigative Site | Tilburg | |
Netherlands | Novartis Investigative Site | Veldhoven | |
Panama | Novartis Investigative Site | Panama City | Panamá |
Panama | Novartis Investigative Site | Panama City | Panamá |
Peru | Novartis Investigative Site | Arequipa | |
Peru | Novartis Investigative Site | Bellavista | Lima |
Peru | Novartis Investigative Site | Cercado de Lima | Lima |
Peru | Novartis Investigative Site | Jesus Maria | Lima |
Peru | Novartis Investigative Site | La Molina | Lima |
Peru | Novartis Investigative Site | San Borja | Lima |
Peru | Novartis Investigative Site | San Isidro | Lima |
Peru | Novartis Investigative Site | San Miguel | Lima |
Philippines | Novartis Investigative Site | Bulacan | |
Philippines | Novartis Investigative Site | Lipa City | Batangas |
Philippines | Novartis Investigative Site | Manila | |
Philippines | Novartis Investigative Site | Manila | |
Philippines | Novartis Investigative Site | Manila | |
Philippines | Novartis Investigative Site | Pasig City | |
Philippines | Novartis Investigative Site | Quezon City | |
Philippines | Novartis Investigative Site | Quezon City | |
Philippines | Novartis Investigative Site | Quezon City | Manila |
Philippines | Novartis Investigative Site | Quezon City | Metro Manila |
Philippines | Novartis Investigative Site | San Juan City | |
Poland | Novartis Investigative Site | Bialystok | |
Poland | Novartis Investigative Site | Gdynia | |
Poland | Novartis Investigative Site | Gdynia | |
Poland | Novartis Investigative Site | Gdynia | |
Poland | Novartis Investigative Site | Gdynia | |
Poland | Novartis Investigative Site | Gliwice | |
Poland | Novartis Investigative Site | Golub-Dobrzyn | |
Poland | Novartis Investigative Site | Katowice | |
Poland | Novartis Investigative Site | Katowice | |
Poland | Novartis Investigative Site | Katowice | |
Poland | Novartis Investigative Site | Krakow | |
Poland | Novartis Investigative Site | Krakow | |
Poland | Novartis Investigative Site | Kutno | |
Poland | Novartis Investigative Site | Lodz | |
Poland | Novartis Investigative Site | Lublin | |
Poland | Novartis Investigative Site | Olawa | |
Poland | Novartis Investigative Site | Skierniewice | |
Poland | Novartis Investigative Site | Wroclaw | |
Poland | Novartis Investigative Site | Wroclaw | |
Poland | Novartis Investigative Site | Wroclaw | |
Poland | Novartis Investigative Site | Zabrze | |
Portugal | Novartis Investigative Site | Amadora | |
Portugal | Novartis Investigative Site | Covilha | |
Portugal | Novartis Investigative Site | Guimarães | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Penafiel | |
Portugal | Novartis Investigative Site | Portalegre | |
Portugal | Novartis Investigative Site | Porto | |
Portugal | Novartis Investigative Site | Setubal | |
Portugal | Novartis Investigative Site | Vila Real | Portuigal |
Romania | Novartis Investigative Site | Arad | |
Romania | Novartis Investigative Site | Bucharest | |
Romania | Novartis Investigative Site | Bucharest | |
Romania | Novartis Investigative Site | Bucharest | |
Romania | Novartis Investigative Site | Bucharest | |
Romania | Novartis Investigative Site | Bucharest | District 1 |
Romania | Novartis Investigative Site | Bucharest | District 5 |
Romania | Novartis Investigative Site | Bucuresti | District 1 |
Romania | Novartis Investigative Site | Bucuresti | District 2 |
Romania | Novartis Investigative Site | Bucuresti | |
Romania | Novartis Investigative Site | Bucuresti | |
Romania | Novartis Investigative Site | Craiova | Jud. Dolj |
Romania | Novartis Investigative Site | Craiova | Jud.Dolj |
Romania | Novartis Investigative Site | Deva | |
Romania | Novartis Investigative Site | Pitesti | |
Romania | Novartis Investigative Site | Ploiesti | Jud.Prahova |
Romania | Novartis Investigative Site | Timisoara | jud. Timis |
Romania | Novartis Investigative Site | Timisoara | |
Romania | Novartis Investigative Site | Timisoara | |
Romania | Novartis Investigative Site | Timisoara | |
Romania | Novartis Investigative Site | Timisoara | |
Romania | Novartis Investigative Site | Timisoara | |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Gatchina | |
Russian Federation | Novartis Investigative Site | Ivanovo | |
Russian Federation | Novartis Investigative Site | Izhevsk | |
Russian Federation | Novartis Investigative Site | Kazan | |
Russian Federation | Novartis Investigative Site | Kemerovo | |
Russian Federation | Novartis Investigative Site | Kemerovo | |
Russian Federation | Novartis Investigative Site | Kemerovo | |
Russian Federation | Novartis Investigative Site | Kirov | |
Russian Federation | Novartis Investigative Site | Krasnodar | |
Russian Federation | Novartis Investigative Site | Krasnodar | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | N. Novgorod | |
Russian Federation | Novartis Investigative Site | N.Novgorod | |
Russian Federation | Novartis Investigative Site | N.Novgorod | |
Russian Federation | Novartis Investigative Site | Nizhnii Novgorod | |
Russian Federation | Novartis Investigative Site | Novosibirsk | |
Russian Federation | Novartis Investigative Site | Novosibirsk | |
Russian Federation | Novartis Investigative Site | Novosibirsk-117 | |
Russian Federation | Novartis Investigative Site | Orenburg | |
Russian Federation | Novartis Investigative Site | Orenburg | |
Russian Federation | Novartis Investigative Site | Penza | |
Russian Federation | Novartis Investigative Site | Perm | |
Russian Federation | Novartis Investigative Site | Petrozavodsk | |
Russian Federation | Novartis Investigative Site | Rostov-on-Don | |
Russian Federation | Novartis Investigative Site | S-Petersburg | |
Russian Federation | Novartis Investigative Site | S.-Petersburg | |
Russian Federation | Novartis Investigative Site | S.-Petersburg | |
Russian Federation | Novartis Investigative Site | Saint Petersburg | |
Russian Federation | Novartis Investigative Site | Saint Petersburg | |
Russian Federation | Novartis Investigative Site | Saint-Petersburg | |
Russian Federation | Novartis Investigative Site | Saint-Petersburg | |
Russian Federation | Novartis Investigative Site | Samara | |
Russian Federation | Novartis Investigative Site | Samara | |
Russian Federation | Novartis Investigative Site | Sankt-Peterburg | |
Russian Federation | Novartis Investigative Site | Saratov | |
Russian Federation | Novartis Investigative Site | Saratov | |
Russian Federation | Novartis Investigative Site | Smolensk | |
Russian Federation | Novartis Investigative Site | St-Peterburg | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Russian Federation | Novartis Investigative Site | St. Petersburg | |
Russian Federation | Novartis Investigative Site | St.Petersburg | |
Russian Federation | Novartis Investigative Site | Syktyvkar | |
Russian Federation | Novartis Investigative Site | Tula | |
Russian Federation | Novartis Investigative Site | Tver | |
Russian Federation | Novartis Investigative Site | Vladimir | |
Russian Federation | Novartis Investigative Site | Volgograd | |
Russian Federation | Novartis Investigative Site | Voronezh | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Singapore | Novartis Investigative Site | Singapore | |
Singapore | Novartis Investigative Site | Singapore | |
Singapore | Novartis Investigative Site | Singapore | |
Singapore | Novartis Investigative Site | Singapore | |
Slovakia | Novartis Investigative Site | Bratislava | Slovak Republic |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Brezno | Slovak Republic |
Slovakia | Novartis Investigative Site | Dolny Kubin | |
Slovakia | Novartis Investigative Site | Dunajska Streda | |
Slovakia | Novartis Investigative Site | Kosice | |
Slovakia | Novartis Investigative Site | Kosice | |
Slovakia | Novartis Investigative Site | Kosice | Slovak Republic |
Slovakia | Novartis Investigative Site | Kralovsky Chlmec | |
Slovakia | Novartis Investigative Site | Levice | |
Slovakia | Novartis Investigative Site | Levice | |
Slovakia | Novartis Investigative Site | Levice | Slovak Republic |
Slovakia | Novartis Investigative Site | Lucenec | |
Slovakia | Novartis Investigative Site | Martin | |
Slovakia | Novartis Investigative Site | Nitra | |
Slovakia | Novartis Investigative Site | Presov | Slovak Republic |
Slovakia | Novartis Investigative Site | Presov | Slovak Republic |
Slovakia | Novartis Investigative Site | Svidnik | Slovak Republic |
Slovakia | Novartis Investigative Site | Trnava | |
Slovakia | Novartis Investigative Site | Trnava | |
Slovakia | Novartis Investigative Site | Vranov nad Toplou | Slovak Republic |
South Africa | Novartis Investigative Site | Alberton | |
South Africa | Novartis Investigative Site | Bloemfontein | |
South Africa | Novartis Investigative Site | Bloemfontein | |
South Africa | Novartis Investigative Site | Bloemfontein | Free State |
South Africa | Novartis Investigative Site | Breyton | |
South Africa | Novartis Investigative Site | Brits | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Durban | |
South Africa | Novartis Investigative Site | Durban | |
South Africa | Novartis Investigative Site | Durban | |
South Africa | Novartis Investigative Site | East London | |
South Africa | Novartis Investigative Site | Gatesville | |
South Africa | Novartis Investigative Site | Johannesburg | |
South Africa | Novartis Investigative Site | Kempton Park | |
South Africa | Novartis Investigative Site | Middelburg | Mpumalanga |
South Africa | Novartis Investigative Site | Mthatha | Eastern Cape |
South Africa | Novartis Investigative Site | Paarl | Western Cape |
South Africa | Novartis Investigative Site | Port Elizabeth | |
South Africa | Novartis Investigative Site | Pretoria | |
South Africa | Novartis Investigative Site | Pretoria | |
South Africa | Novartis Investigative Site | Pretoria | |
South Africa | Novartis Investigative Site | Somerset West | Western Cape |
South Africa | Novartis Investigative Site | Soweto | Gauteng |
South Africa | Novartis Investigative Site | Umkomaas | |
South Africa | Novartis Investigative Site | Witbank | |
South Africa | Novartis Investigative Site | Worcester | |
Spain | Novartis Investigative Site | A Coruna | Galicia |
Spain | Novartis Investigative Site | Alcala de Henares | Madrid |
Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
Spain | Novartis Investigative Site | Almeria | Andalucia |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | El Palmar | Murcia |
Spain | Novartis Investigative Site | Ferrol | Galicia |
Spain | Novartis Investigative Site | La Coruna | Galicia |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Majadahonda | Madrid |
Spain | Novartis Investigative Site | Malaga | Andalucia |
Spain | Novartis Investigative Site | Mallorca | Islas Baleares |
Spain | Novartis Investigative Site | Marbella | Andalucia |
Spain | Novartis Investigative Site | Mérida | Extremadura |
Spain | Novartis Investigative Site | Mostoles | Madrid |
Spain | Novartis Investigative Site | Sant Joan Despi | Cataluna |
Spain | Novartis Investigative Site | Santiago de Compostela | Galicia |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
Spain | Novartis Investigative Site | Vigo | Galicia |
Sweden | Novartis Investigative Site | Göteborg | |
Sweden | Novartis Investigative Site | Göteborg | |
Sweden | Novartis Investigative Site | Härnösand | |
Sweden | Novartis Investigative Site | Helsingborg | |
Sweden | Novartis Investigative Site | Karlshamn | |
Sweden | Novartis Investigative Site | Lund | |
Sweden | Novartis Investigative Site | Motala | |
Sweden | Novartis Investigative Site | Stockholm | |
Sweden | Novartis Investigative Site | Vällingby | |
Taiwan | Novartis Investigative Site | Changhua | |
Taiwan | Novartis Investigative Site | Ilan | |
Taiwan | Novartis Investigative Site | Kaohsiung | |
Taiwan | Novartis Investigative Site | Taichung | |
Taiwan | Novartis Investigative Site | Tainan 704 | Taiwan ROC |
Taiwan | Novartis Investigative Site | Taipei | Taiwan, ROC |
Taiwan | Novartis Investigative Site | Taipei | |
Taiwan | Novartis Investigative Site | Taipei | |
Thailand | Novartis Investigative Site | Bangkok | |
Thailand | Novartis Investigative Site | Khon Kaen | |
Thailand | Novartis Investigative Site | Muang | |
Thailand | Novartis Investigative Site | Muang | |
Thailand | Novartis Investigative Site | Taladkwan | Nonthaburi |
Turkey | Novartis Investigative Site | Adana | |
Turkey | Novartis Investigative Site | Ankara | |
Turkey | Novartis Investigative Site | Antalya | |
Turkey | Novartis Investigative Site | Balcova / Izmir | |
Turkey | Novartis Investigative Site | Edirne | |
Turkey | Novartis Investigative Site | Etlik / Ankara | |
Turkey | Novartis Investigative Site | Haseki / Istanbul | |
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Izmir | |
Turkey | Novartis Investigative Site | Kocaeli | |
Turkey | Novartis Investigative Site | Mersin | |
Turkey | Novartis Investigative Site | Meselik / Eskisehir | |
Turkey | Novartis Investigative Site | Sivas | |
United Kingdom | Novartis Investigative Site | Basingstoke | Hampshire |
United Kingdom | Novartis Investigative Site | Birmingham | |
United Kingdom | Novartis Investigative Site | Blackpool | |
United Kingdom | Novartis Investigative Site | Bournemouth | |
United Kingdom | Novartis Investigative Site | Bradford | |
United Kingdom | Novartis Investigative Site | Brighton | East Sussex |
United Kingdom | Novartis Investigative Site | Bristol | Bs2 8hw |
United Kingdom | Novartis Investigative Site | Cambridge | Cambrigdeshire |
United Kingdom | Novartis Investigative Site | Cheshire | |
United Kingdom | Novartis Investigative Site | Coventry | |
United Kingdom | Novartis Investigative Site | Craigavon | Northern Ireland |
United Kingdom | Novartis Investigative Site | Croydon | |
United Kingdom | Novartis Investigative Site | Darlington | |
United Kingdom | Novartis Investigative Site | Dorchester | Dorset |
United Kingdom | Novartis Investigative Site | Dudley | West Midlands |
United Kingdom | Novartis Investigative Site | Dundee | Perthshire |
United Kingdom | Novartis Investigative Site | Durham | County Durham |
United Kingdom | Novartis Investigative Site | Exeter | |
United Kingdom | Novartis Investigative Site | Inverness | |
United Kingdom | Novartis Investigative Site | Kent | |
United Kingdom | Novartis Investigative Site | Leicester | Leicestershire |
United Kingdom | Novartis Investigative Site | Liverpool | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Londonderry | |
United Kingdom | Novartis Investigative Site | Manchester | |
United Kingdom | Novartis Investigative Site | Middlesborough | |
United Kingdom | Novartis Investigative Site | Milton Keynes | |
United Kingdom | Novartis Investigative Site | Newport | |
United Kingdom | Novartis Investigative Site | Newport | |
United Kingdom | Novartis Investigative Site | Norwich | |
United Kingdom | Novartis Investigative Site | Oldham | Lancashire |
United Kingdom | Novartis Investigative Site | Poole | |
United Kingdom | Novartis Investigative Site | Portsmouth | Hampshire |
United Kingdom | Novartis Investigative Site | Redhill | Surrey |
United Kingdom | Novartis Investigative Site | Romford | Essex |
United Kingdom | Novartis Investigative Site | Rotherham | |
United Kingdom | Novartis Investigative Site | Royal Bridge Wells | Kent |
United Kingdom | Novartis Investigative Site | Sheffield | South Yorkshire |
United Kingdom | Novartis Investigative Site | South Shields | Tyne and Wear |
United Kingdom | Novartis Investigative Site | Stevenage | |
United Kingdom | Novartis Investigative Site | Sunderland | |
United Kingdom | Novartis Investigative Site | Surrey | |
United Kingdom | Novartis Investigative Site | Sutton Coldfield | West Midlands |
United Kingdom | Novartis Investigative Site | Swansea | England |
United Kingdom | Novartis Investigative Site | Taunton | Somerset |
United Kingdom | Novartis Investigative Site | Vale of Glamorgan | |
United Kingdom | Novartis Investigative Site | Worcester | |
United Kingdom | Novartis Investigative Site | Yeovil | Somerset |
United Kingdom | Novartis Investigative Site | York | |
United States | Novartis Investigative Site | Albuquerque | New Mexico |
United States | Novartis Investigative Site | Alexandria | Louisiana |
United States | Novartis Investigative Site | Aliquippa | Pennsylvania |
United States | Novartis Investigative Site | Amarillo | Texas |
United States | Novartis Investigative Site | Anaheim | California |
United States | Novartis Investigative Site | Anchorage | Alaska |
United States | Novartis Investigative Site | Ann Arbor | Michigan |
United States | Novartis Investigative Site | Arlington | Texas |
United States | Novartis Investigative Site | Asheboro | North Carolina |
United States | Novartis Investigative Site | Asheville | North Carolina |
United States | Novartis Investigative Site | Ayer | Massachusetts |
United States | Novartis Investigative Site | Baltimore | Maryland |
United States | Novartis Investigative Site | Bartlesville | Oklahoma |
United States | Novartis Investigative Site | Beaumont | Texas |
United States | Novartis Investigative Site | Beaumont | Texas |
United States | Novartis Investigative Site | Beaver | Pennsylvania |
United States | Novartis Investigative Site | Bellflower | California |
United States | Novartis Investigative Site | Beltsville | Maryland |
United States | Novartis Investigative Site | Berkley | California |
United States | Novartis Investigative Site | Biddeford | Maine |
United States | Novartis Investigative Site | Birmingham | Alabama |
United States | Novartis Investigative Site | Birmingham | Alabama |
United States | Novartis Investigative Site | Boston | Massachusetts |
United States | Novartis Investigative Site | Boynton Beach | Florida |
United States | Novartis Investigative Site | Brownsville | Texas |
United States | Novartis Investigative Site | Cadiz | Ohio |
United States | Novartis Investigative Site | Canton | Ohio |
United States | Novartis Investigative Site | Cary | North Carolina |
United States | Novartis Investigative Site | Charleston | South Carolina |
United States | Novartis Investigative Site | Chicago | Illinois |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Cleveland | Ohio |
United States | Novartis Investigative Site | Columbia | Maryland |
United States | Novartis Investigative Site | Columbus | Ohio |
United States | Novartis Investigative Site | Cordtlandt Manor | New York |
United States | Novartis Investigative Site | Covington | Louisiana |
United States | Novartis Investigative Site | Covington | Georgia |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Davie | Florida |
United States | Novartis Investigative Site | Decatur | Georgia |
United States | Novartis Investigative Site | Denver | Colorado |
United States | Novartis Investigative Site | Denver | Colorado |
United States | Novartis Investigative Site | Des Moines | Iowa |
United States | Novartis Investigative Site | Detroit | Michigan |
United States | Novartis Investigative Site | Elizabeth | New Jersey |
United States | Novartis Investigative Site | Fort Lauderdale | Florida |
United States | Novartis Investigative Site | Fredericksburg | Virginia |
United States | Novartis Investigative Site | Fremont | Nebraska |
United States | Novartis Investigative Site | Gainesville | Florida |
United States | Novartis Investigative Site | Gilbert | Arizona |
United States | Novartis Investigative Site | Grand Island | Nebraska |
United States | Novartis Investigative Site | Grapevine | Texas |
United States | Novartis Investigative Site | Greensboro | North Carolina |
United States | Novartis Investigative Site | Hamilton | New Jersey |
United States | Novartis Investigative Site | Haverhill | Massachusetts |
United States | Novartis Investigative Site | Honolulu | Hawaii |
United States | Novartis Investigative Site | Honolulu | Hawaii |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Huntsville | Alabama |
United States | Novartis Investigative Site | Jacksonville | Florida |
United States | Novartis Investigative Site | Jacksonville | Florida |
United States | Novartis Investigative Site | Jacksonville | Florida |
United States | Novartis Investigative Site | Kingwood | Texas |
United States | Novartis Investigative Site | Lafayette | Louisiana |
United States | Novartis Investigative Site | Lakeland | Florida |
United States | Novartis Investigative Site | Lapeer | Michigan |
United States | Novartis Investigative Site | Laurelton | New York |
United States | Novartis Investigative Site | Layton | Utah |
United States | Novartis Investigative Site | Leesburg | Florida |
United States | Novartis Investigative Site | Little Rock | Arkansas |
United States | Novartis Investigative Site | Little Rock | Arkansas |
United States | Novartis Investigative Site | Livingston | Texas |
United States | Novartis Investigative Site | Loma Linda | California |
United States | Novartis Investigative Site | Los Angeles | California |
United States | Novartis Investigative Site | Los Angeles | California |
United States | Novartis Investigative Site | Lufkin | Texas |
United States | Novartis Investigative Site | Madison | Wisconsin |
United States | Novartis Investigative Site | Marion | Ohio |
United States | Novartis Investigative Site | Mather | California |
United States | Novartis Investigative Site | Maywood | Illinois |
United States | Novartis Investigative Site | Melrose Park | Illinois |
United States | Novartis Investigative Site | Memphis | Tennessee |
United States | Novartis Investigative Site | Milwaukee | Wisconsin |
United States | Novartis Investigative Site | Minneapolis | Minnesota |
United States | Novartis Investigative Site | Mobile | Alabama |
United States | Novartis Investigative Site | Muscle Shoals | Alabama |
United States | Novartis Investigative Site | Nashua | New Hampshire |
United States | Novartis Investigative Site | Nashville | Tennessee |
United States | Novartis Investigative Site | Nashville | Tennessee |
United States | Novartis Investigative Site | Natick | Massachusetts |
United States | Novartis Investigative Site | New Brunswick | New Jersey |
United States | Novartis Investigative Site | New York | New York |
United States | Novartis Investigative Site | Newark | New Jersey |
United States | Novartis Investigative Site | Northport | New York |
United States | Novartis Investigative Site | Nottingham | Maryland |
United States | Novartis Investigative Site | Ocean | New Jersey |
United States | Novartis Investigative Site | Oceanside | California |
United States | Novartis Investigative Site | Odessa | Texas |
United States | Novartis Investigative Site | Oklahoma City | Oklahoma |
United States | Novartis Investigative Site | Oklahoma City | Oklahoma |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Palm Springs | California |
United States | Novartis Investigative Site | Park Ridge | Illinois |
United States | Novartis Investigative Site | Philadelphia | Pennsylvania |
United States | Novartis Investigative Site | Phoenix | Arizona |
United States | Novartis Investigative Site | Phoenix | Arizona |
United States | Novartis Investigative Site | Picayune | Mississippi |
United States | Novartis Investigative Site | Pittsburgh | Pennsylvania |
United States | Novartis Investigative Site | Plano | Texas |
United States | Novartis Investigative Site | Pomona | California |
United States | Novartis Investigative Site | Port Charlotte | Florida |
United States | Novartis Investigative Site | Portland | Oregon |
United States | Novartis Investigative Site | Pratt | Kansas |
United States | Novartis Investigative Site | Quincy | Illinois |
United States | Novartis Investigative Site | Raleigh | North Carolina |
United States | Novartis Investigative Site | Rapid City | South Dakota |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigative Site | Rolling Fork | Mississippi |
United States | Novartis Investigative Site | Sacramento | California |
United States | Novartis Investigative Site | Saginaw | Michigan |
United States | Novartis Investigative Site | San Diego | California |
* Note: There are 1030 locations in all - only the first 1000 are shown. |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Venezuela, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, Iceland, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF. | up to 51 months | No |
Secondary | Number of Patients - All-cause Mortality | Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014 | up to 51 months | Yes |
Secondary | Number of Patients Reported With Adjudicated Primary Causes of Death | Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014 | up to 51 months | Yes |
Secondary | Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Baseline, Month 8 | No |
Secondary | Number of Patients With First Confirmed Renal Dysfunction | Number of patients with first confirmed renal dysfunction | up to 51 months | No |
Secondary | Percentage of Participants With New Onset of Atrial Fibrillation (AF) | Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis). | up to 51 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
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||
Completed |
NCT03614169 -
Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB
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N/A | |
Recruiting |
NCT05278962 -
HF Patients With LVADs Being Treated With SGLT2i
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Phase 4 | |
Completed |
NCT04210375 -
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
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Phase 1 | |
Not yet recruiting |
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Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
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||
Completed |
NCT05001165 -
Dashboard Activated Services and Tele-Health for Heart Failure
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N/A | |
Active, not recruiting |
NCT03701880 -
Early Use of Ivabradine in Heart Failure
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N/A | |
Recruiting |
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Left vs Left Randomized Clinical Trial
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N/A | |
Not yet recruiting |
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Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
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Recruiting |
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Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
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Recruiting |
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Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study
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N/A | |
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
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||
Not yet recruiting |
NCT04420065 -
Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure
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N/A | |
Terminated |
NCT03479424 -
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
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||
Completed |
NCT02113033 -
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
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Phase 2 | |
Recruiting |
NCT03209180 -
Immediate Release Versus Slow Release Carvedilol in Heart Failure
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Phase 4 | |
Recruiting |
NCT05299879 -
Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
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Recruiting |
NCT05637853 -
Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
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Completed |
NCT03870074 -
CPET Predicts Long-term Survival and Positive Response to CRT
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Recruiting |
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Effect of the MobiusHD® in Patients With Heart Failure
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N/A |