Chronic Heart Failure Clinical Trial
— ATMOSPHEREOfficial title:
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV).
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
Status | Completed |
Enrollment | 7126 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a diagnosis of chronic heart failure (NYHA Class II - IV): - LVEF = 35% at visit 1. (local measurement, measured within the past 6 months assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography) - Elevated BNP at visit 1: BNP = 150 pg/ml (according to local measurement). - BNP = 100 pg/ml (according to local measurement) and unplanned hospitalization with HF within the last 12 months prior visit 1. - Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg daily at least or any other ACE inhibitor, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses as described in the dose equivalence guidance table of ACEi's) for at least 4 weeks prior to visit 1 Exclusion Criteria: - History of hypersensitivity to any of the study drugs including history or allergy to ACEi's as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEi's during up titration process. - Patients treated concomitantly with both ARB and aldosterone antagonist in addition to study drug at visit 1. - Current acute decompensated HF. - Symptomatic hypotension and/or less than 95 mmHg SBP at visit 1 and/or less than 90 mmHg at visit 4. - Renal disease likely to be life threatening or eGFR < 40 ml/min/1.73m2 as measured by the MDRD formula at visit 1 and eGFR < 35 ml/min/1.73m2 as measured by the MDRD formula at visit 4 or decrease of eGFR of more than 25% from visit 1 to visit 4 (according to local laboratory measurement). - Serum potassium = 5.0 mmol/L at visit 1 or = 5.2 mmol/L at visit 4 (according to local laboratory measurement). - Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to visit 1. - Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after visit 1. - Right heart failure due to severe pulmonary disease - Patients with diabetes mellitus - Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Argentina | Novartis Investigative Site | Bahia Blanca | Buenos Aires |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Cordoba | |
Argentina | Novartis Investigative Site | Cordoba | |
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Japan | Novartis Investigative Site | Kanazawa | Ishikawa |
Japan | Novartis Investigative Site | Kashihara-city | Nara |
Japan | Novartis Investigative Site | Kawasaki-city | Kanagawa |
Japan | Novartis Investigative Site | Kita-ku | Osaka |
Japan | Novartis Investigative Site | Komatsushima-city | Tokushima |
Japan | Novartis Investigative Site | Kumamoto City | Kumamoto |
Japan | Novartis Investigative Site | Kure | Hiroshima |
Japan | Novartis Investigative Site | Kurume-city | Fukuoka |
Japan | Novartis Investigative Site | Nagasaki | |
Japan | Novartis Investigative Site | Nagoya-city | Aichi |
Japan | Novartis Investigative Site | Ogaki-city | Gifu |
Japan | Novartis Investigative Site | Okayama-city | Okayama |
Japan | Novartis Investigative Site | Osaka-city | Osaka |
Japan | Novartis Investigative Site | Saga | |
Japan | Novartis Investigative Site | Sagamihara-city | Kanagawa |
Japan | Novartis Investigative Site | Sapporo-city | Hokkaido |
Japan | Novartis Investigative Site | Sapporo-city | Hokkaido |
Japan | Novartis Investigative Site | Sendai-city | Miyagi |
Japan | Novartis Investigative Site | Seto-city | Aichi |
Japan | Novartis Investigative Site | Shinjuku-ku | Tokyo |
Japan | Novartis Investigative Site | Shunan-city | Yamaguchi |
Japan | Novartis Investigative Site | Tokushima-city | Tokushima |
Japan | Novartis Investigative Site | Toyama | |
Japan | Novartis Investigative Site | Tsukuba-city | Ibaraki |
Japan | Novartis Investigative Site | Ube | Yamaguchi |
Japan | Novartis Investigative Site | Ureshino | Saga |
Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
Japan | Novartis Investigative Site | Yokosuka | Kanagawa |
Korea, Republic of | Novartis Investigative Site | Busan | |
Korea, Republic of | Novartis Investigative Site | Daejeon | |
Korea, Republic of | Novartis Investigative Site | Gwangju | |
Korea, Republic of | Novartis Investigative Site | Incheon | |
Korea, Republic of | Novartis Investigative Site | Seongnam | Gyeonggi |
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 | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Taegu | |
Latvia | Novartis Investigative Site | Daugavpils | |
Latvia | Novartis Investigative Site | Riga | |
Latvia | Novartis Investigative Site | Riga | |
Latvia | Novartis Investigative Site | Riga | |
Lithuania | Novartis Investigative Site | Kaunas | LTU |
Lithuania | Novartis Investigative Site | Kaunas | |
Lithuania | Novartis Investigative Site | Klaipeda | |
Lithuania | Novartis Investigative Site | Vilnius | |
Mexico | Novartis Investigative Site | Aguascalientes | |
Mexico | Novartis Investigative Site | Culiacan | Sinaloa |
Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
Mexico | Novartis Investigative Site | Monterrey | Nuevo León |
Mexico | Novartis Investigative Site | Monterrey | Nuevo León |
Mexico | Novartis Investigative Site | Querétaro | |
Mexico | Novartis Investigative Site | San Luis Potosi | |
Mexico | Novartis Investigative Site | Zapopan | Jalisco |
Netherlands | Novartis Investigative Site | Alkmaar | |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Apeldoorn | |
Netherlands | Novartis Investigative Site | Deventer | |
Netherlands | Novartis Investigative Site | Dirksland | |
Netherlands | Novartis Investigative Site | Enschede | |
Netherlands | Novartis Investigative Site | Groningen | |
Netherlands | Novartis Investigative Site | Haarlem | |
Netherlands | Novartis Investigative Site | Heerlen | |
Netherlands | Novartis Investigative Site | Leeuwarden | |
Netherlands | Novartis Investigative Site | Leiderdorp | |
Netherlands | Novartis Investigative Site | Meppel | |
Netherlands | Novartis Investigative Site | Rotterdam | |
Netherlands | Novartis Investigative Site | Rotterdam | |
Netherlands | Novartis Investigative Site | Venlo | |
Netherlands | Novartis Investigative Site | Wildervank | |
Netherlands | Novartis Investigative Site | Zutphen | |
Netherlands | Novartis Investigative Site | Zwolle | |
Norway | Novartis Investigative Site | Oslo | |
Norway | Novartis Investigative Site | Tønsberg | |
Norway | Novartis Investigative Site | Trondheim | |
Peru | Novartis Investigative Site | Bellavista | Lima |
Peru | Novartis Investigative Site | Cercado de Lima | Lima |
Peru | Novartis Investigative Site | Chiclayo | Lambayeque |
Peru | Novartis Investigative Site | Jesus Maria | Lima |
Peru | Novartis Investigative Site | Lima | |
Peru | Novartis Investigative Site | Miraflores | Lima |
Peru | Novartis Investigative Site | San Borja | Lima |
Peru | Novartis Investigative Site | San Isidro | Lima |
Peru | Novartis Investigative Site | San Juan de Miraflores | Lima |
Peru | Novartis Investigative Site | Trujillo | La Libertad |
Poland | Novartis Investigative Site | Bytom | |
Poland | Novartis Investigative Site | Chorzow | |
Poland | Novartis Investigative Site | Gdansk | |
Poland | Novartis Investigative Site | Gdynia | |
Poland | Novartis Investigative Site | Gdynia | |
Poland | Novartis Investigative Site | Gliwice | |
Poland | Novartis Investigative Site | Grodzisk Mazowiecki | |
Poland | Novartis Investigative Site | Katowice | |
Poland | Novartis Investigative Site | Katowice | |
Poland | Novartis Investigative Site | Klodzko | |
Poland | Novartis Investigative Site | Krakow | |
Poland | Novartis Investigative Site | Kraków | |
Poland | Novartis Investigative Site | Lomza | |
Poland | Novartis Investigative Site | Olawa | |
Poland | Novartis Investigative Site | Opole | |
Poland | Novartis Investigative Site | Ostrow Wielkopolski | |
Poland | Novartis Investigative Site | Ostrowiec Swietokrzyski | |
Poland | Novartis Investigative Site | Piotrkow Trybunalski | |
Poland | Novartis Investigative Site | Plock | |
Poland | Novartis Investigative Site | Poznan | |
Poland | Novartis Investigative Site | Sandomierz | |
Poland | Novartis Investigative Site | Tarnow | |
Poland | Novartis Investigative Site | Torun | |
Poland | Novartis Investigative Site | Warszawa | |
Poland | Novartis Investigative Site | Warszawa | |
Poland | Novartis Investigative Site | Wroclaw | |
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 | Aveiro | |
Portugal | Novartis Investigative Site | Carnaxide | |
Portugal | Novartis Investigative Site | Coimbra | |
Portugal | Novartis Investigative Site | Faro | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Penafiel | |
Portugal | Novartis Investigative Site | Porto | |
Puerto Rico | Novartis Investigative Site | Humacao | |
Puerto Rico | Novartis Investigative Site | Ponce | |
Puerto Rico | Novartis Investigative Site | San Juan | |
Romania | Novartis Investigative Site | Baia Mare | |
Romania | Novartis Investigative Site | Brasov | |
Romania | Novartis Investigative Site | Brasov | |
Romania | Novartis Investigative Site | Bucharest | District 1 |
Romania | Novartis Investigative Site | Bucharest | District 1 |
Romania | Novartis Investigative Site | Bucharest | District 2 |
Romania | Novartis Investigative Site | Cluj Napoca | |
Romania | Novartis Investigative Site | Cluj-Napoca | |
Romania | Novartis Investigative Site | Iasi | |
Romania | Novartis Investigative Site | Iasi | Jud. Iasi |
Romania | Novartis Investigative Site | Iasi | Jud. Iasi |
Romania | Novartis Investigative Site | Oradea | |
Romania | Novartis Investigative Site | Pitesti | |
Romania | Novartis Investigative Site | Targu Mures | |
Romania | Novartis Investigative Site | Targu Mures | jud Mures |
Romania | Novartis Investigative Site | Targu Mures | Mures |
Romania | Novartis Investigative Site | Timisoara | |
Romania | Novartis Investigative Site | Timisoara | |
Russian Federation | Novartis Investigative Site | Barnaul | |
Russian Federation | Novartis Investigative Site | Chelyabinsk | |
Russian Federation | Novartis Investigative Site | Chelyabinsk | |
Russian Federation | Novartis Investigative Site | Chelyabinsk | |
Russian Federation | Novartis Investigative Site | Chelyabinsk | |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Izhevsk | |
Russian Federation | Novartis Investigative Site | Kirov | |
Russian Federation | Novartis Investigative Site | Krasnodar | |
Russian Federation | Novartis Investigative Site | Kursk | |
Russian Federation | Novartis Investigative Site | Lubertsi | |
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 | Nizhny Novgorod | |
Russian Federation | Novartis Investigative Site | Novosibirsk | |
Russian Federation | Novartis Investigative Site | Novosibirsk | |
Russian Federation | Novartis Investigative Site | Novosibirsk | |
Russian Federation | Novartis Investigative Site | Omsk | |
Russian Federation | Novartis Investigative Site | Perm | |
Russian Federation | Novartis Investigative Site | Pushkin,St-Petersburg | |
Russian Federation | Novartis Investigative Site | Ryazan | |
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 | Saratov | |
Russian Federation | Novartis Investigative Site | Saratov | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Russian Federation | Novartis Investigative Site | St. Petersburg | |
Russian Federation | Novartis Investigative Site | Tyumen | |
Russian Federation | Novartis Investigative Site | Volgograd | |
Russian Federation | Novartis Investigative Site | Volgograd | |
Russian Federation | Novartis Investigative Site | Voronezh | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Slovakia | Novartis Investigative Site | Bardejov | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Bratislava | Slovak Republic |
Slovakia | Novartis Investigative Site | Bratislava | Slovak Republic |
Slovakia | Novartis Investigative Site | Komarno | Slovak Republic |
Slovakia | Novartis Investigative Site | Kosice | Slovak Republic |
Slovakia | Novartis Investigative Site | Kosice | Slovak republic |
Slovakia | Novartis Investigative Site | Kosice | |
Slovakia | Novartis Investigative Site | Kosice | |
Slovakia | Novartis Investigative Site | Levice | Slovak Republic |
Slovakia | Novartis Investigative Site | Lucenec | |
Slovakia | Novartis Investigative Site | Nitra | Slovak Republic |
Slovakia | Novartis Investigative Site | Piestany | |
Slovakia | Novartis Investigative Site | Povazska Bystrica | Slovak republic |
Slovakia | Novartis Investigative Site | Presov | Slovak republic |
Slovakia | Novartis Investigative Site | Presov | |
Slovakia | Novartis Investigative Site | Stropkov | Slovak republic |
Slovakia | Novartis Investigative Site | Trebisov | |
Slovakia | Novartis Investigative Site | Trencin | |
Slovakia | Novartis Investigative Site | Zilina | |
Slovakia | Novartis Investigative Site | Zilina | Slovak Republic |
Slovakia | Novartis Investigative Site | Zilina | Slovak Republic |
South Africa | Novartis Investigative Site | Benoni | |
South Africa | Novartis Investigative Site | Boksburg | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Centurion | |
South Africa | Novartis Investigative Site | Johannesburg | |
South Africa | Novartis Investigative Site | Soweto | Gauteng |
South Africa | Novartis Investigative Site | Worcester | |
Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
Spain | Novartis Investigative Site | Badalona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | |
Spain | Novartis Investigative Site | Hospitalet de Llobregat | Barcelona |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Majadahonda | Madrid |
Spain | Novartis Investigative Site | Oviedo | Asturias |
Spain | Novartis Investigative Site | Sanlucar de Barrameda | Andalucia |
Spain | Novartis Investigative Site | Santiago de Compostela | Galicia |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Spain | Novartis Investigative Site | Tarragona | Catalunya |
Spain | Novartis Investigative Site | Tortosa | Cataluña |
Spain | Novartis Investigative Site | Utrera | Andalucia |
Spain | Novartis Investigative Site | Valdemoro | Madrid |
Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
Spain | Novartis Investigative Site | Villamartin | Cadiz |
Sweden | Novartis Investigative Site | Falun | |
Sweden | Novartis Investigative Site | Göteborg | |
Sweden | Novartis Investigative Site | Karlstad | |
Sweden | Novartis Investigative Site | Linkoping | |
Sweden | Novartis Investigative Site | Lund | |
Sweden | Novartis Investigative Site | Malmo | |
Sweden | Novartis Investigative Site | Malmö | |
Sweden | Novartis Investigative Site | Malmö | |
Sweden | Novartis Investigative Site | Mölndal | |
Sweden | Novartis Investigative Site | Nässjö | |
Sweden | Novartis Investigative Site | Örebro | |
Sweden | Novartis Investigative Site | Skelleftea | |
Sweden | Novartis Investigative Site | Stockholm | |
Sweden | Novartis Investigative Site | Stockholm | |
Sweden | Novartis Investigative Site | Stockholm | |
Sweden | Novartis Investigative Site | Stockholm | |
Sweden | Novartis Investigative Site | Sundsvall | |
Sweden | Novartis Investigative Site | Sundsvall | |
Sweden | Novartis Investigative Site | Umeå | |
Sweden | Novartis Investigative Site | Uppsala | |
Sweden | Novartis Investigative Site | Västerås | |
Switzerland | Novartis Investigative Site | Basel | |
Switzerland | Novartis Investigative Site | Bellinzona | |
Switzerland | Novartis Investigative Site | Bern | |
Switzerland | Novartis Investigative Site | Biel | |
Switzerland | Novartis Investigative Site | Bruderholz | |
Switzerland | Novartis Investigative Site | Lugano | |
Switzerland | Novartis Investigative Site | Olten | |
Switzerland | Novartis Investigative Site | Winterthur | |
Switzerland | Novartis Investigative Site | Zuerich | |
Taiwan | Novartis Investigative Site | Kaohsiung | |
Taiwan | Novartis Investigative Site | Lin-Kou | |
Taiwan | Novartis Investigative Site | Niaosong Township | |
Taiwan | Novartis Investigative Site | Taichung | |
Taiwan | Novartis Investigative Site | Tainan 704 | Taiwan ROC |
Taiwan | Novartis Investigative Site | Taipei | |
Taiwan | Novartis Investigative Site | Taipei | |
Taiwan | Novartis Investigative Site | Yungkang | Tainan |
Thailand | Novartis Investigative Site | Bangkok | |
Thailand | Novartis Investigative Site | Bangkok | |
Thailand | Novartis Investigative Site | Bangkok | |
Thailand | Novartis Investigative Site | Chiang Mai | |
Turkey | Novartis Investigative Site | Ankara | |
Turkey | Novartis Investigative Site | Aydin | |
Turkey | Novartis Investigative Site | Balcova | |
Turkey | Novartis Investigative Site | Etlik / Ankara | |
Turkey | Novartis Investigative Site | Fatih / Istanbul | |
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Izmir | |
Turkey | Novartis Investigative Site | Kinikli / Denizli | |
Turkey | Novartis Investigative Site | Kocaeli | |
Turkey | Novartis Investigative Site | Sivas | |
United Kingdom | Novartis Investigative Site | Addlestone | Surrey |
United Kingdom | Novartis Investigative Site | Cardiff | |
United Kingdom | Novartis Investigative Site | Chesterfield | |
United Kingdom | Novartis Investigative Site | Chichester | West Sussex |
United Kingdom | Novartis Investigative Site | Colchester | |
United Kingdom | Novartis Investigative Site | Dafen | Llanelli |
United Kingdom | Novartis Investigative Site | East Yorkshire | |
United Kingdom | Novartis Investigative Site | Glasgow | |
United Kingdom | Novartis Investigative Site | Leicester | Leicestershire |
United Kingdom | Novartis Investigative Site | Liverpool | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Manchester | |
United Kingdom | Novartis Investigative Site | Southampton | |
United Kingdom | Novartis Investigative Site | Swindon | |
United Kingdom | Novartis Investigative Site | Worthing | West Sussex |
United States | Novartis Investigative Site | Athens | Georgia |
United States | Novartis Investigative Site | Auburn | Maine |
United States | Novartis Investigative Site | Augusta | Georgia |
United States | Novartis Investigative Site | Beverly Hills | California |
United States | Novartis Investigative Site | Boynton Beach | Florida |
United States | Novartis Investigative Site | Charleston | South Carolina |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Daytona Beach | Florida |
United States | Novartis Investigative Site | Denver | Colorado |
United States | Novartis Investigative Site | Durham | North Carolina |
United States | Novartis Investigative Site | Elmer | New Jersey |
United States | Novartis Investigative Site | Everett | Washington |
United States | Novartis Investigative Site | Fort Lauderdale | Florida |
United States | Novartis Investigative Site | French Camp | California |
United States | Novartis Investigative Site | Germantown | Tennessee |
United States | Novartis Investigative Site | Gillespie | Illinois |
United States | Novartis Investigative Site | Hollywood | Florida |
United States | Novartis Investigative Site | Hot Springs | Arkansas |
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 | Inglewood | California |
United States | Novartis Investigative Site | Jacksonville Beach | Florida |
United States | Novartis Investigative Site | Kirkland | Washington |
United States | Novartis Investigative Site | Laurelton | New York |
United States | Novartis Investigative Site | Lincoln | Nebraska |
United States | Novartis Investigative Site | Little Rock | Arkansas |
United States | Novartis Investigative Site | Little Rock | Arkansas |
United States | Novartis Investigative Site | Littleton | Colorado |
United States | Novartis Investigative Site | Los Angeles | California |
United States | Novartis Investigative Site | Marion | Ohio |
United States | Novartis Investigative Site | Memphis | Tennessee |
United States | Novartis Investigative Site | Metairie | Louisiana |
United States | Novartis Investigative Site | Miami Lakes | Florida |
United States | Novartis Investigative Site | Mobile | Alabama |
United States | Novartis Investigative Site | Mobile | Alabama |
United States | Novartis Investigative Site | Modesto | California |
United States | Novartis Investigative Site | Nashville | Tennessee |
United States | Novartis Investigative Site | Nashville | Tennessee |
United States | Novartis Investigative Site | New Orleans | Louisiana |
United States | Novartis Investigative Site | Northridge | California |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Orlando | Florida |
United States | Novartis Investigative Site | Pine Bluff | Arkansas |
United States | Novartis Investigative Site | Sacramento | California |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | Santa Monica | California |
United States | Novartis Investigative Site | Searcy | Arkansas |
United States | Novartis Investigative Site | Slidell | Louisiana |
United States | Novartis Investigative Site | Southfield | Michigan |
United States | Novartis Investigative Site | St. Louis | Missouri |
United States | Novartis Investigative Site | Stony Brook | New York |
United States | Novartis Investigative Site | Topeka | Kansas |
United States | Novartis Investigative Site | Tucson | Arizona |
United States | Novartis Investigative Site | Varnville | South Carolina |
United States | Novartis Investigative Site | Wellington | Florida |
United States | Novartis Investigative Site | Westlake Village | California |
United States | Novartis Investigative Site | Wiliamsville | New York |
Venezuela | Novartis Investigative Site | Barcelona | Estado Anzoátegui |
Venezuela | Novartis Investigative Site | Caracas | Distrito Capital |
Venezuela | Novartis Investigative Site | Caracas | Distrito Capital |
Venezuela | Novartis Investigative Site | Caracas | Distrito Capital |
Venezuela | Novartis Investigative Site | Caracas | Estado Miranda |
Venezuela | Novartis Investigative Site | Cumana | Estado Sucre |
Venezuela | Novartis Investigative Site | Maracaibo | Estado Zulia |
Venezuela | Novartis Investigative Site | Puerto Ordaz | Estado Bolívar |
Venezuela | Novartis Investigative Site | Valencia | Edo. Carabobo |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Venezuela, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delaying time to first occurrence of either cardiovascular death or heart failure hospitalization in patients with chronic heart failure | 4 years | No | |
Secondary | Improvement in the clinical summary score (assessed by KCCQ) from baseline to predefined timepoint. | 1 year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03597646 -
The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure
|
N/A | |
Terminated |
NCT04065997 -
Apogee International
|
||
Withdrawn |
NCT03675113 -
Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
|
N/A | |
Completed |
NCT02916160 -
Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study
|
Phase 4 | |
Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
Completed |
NCT02268500 -
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
|
Phase 4 | |
Completed |
NCT02247245 -
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
|
N/A | |
Completed |
NCT01919918 -
Muscle Afferent Feedback Effects in Patients With Heart Failure
|
Phase 1 | |
Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
Not yet recruiting |
NCT01669395 -
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
|
N/A | |
Completed |
NCT00984529 -
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
|
N/A | |
Recruiting |
NCT00863421 -
Sleep Disordered Breathing in Patients With Chronic Heart Failure
|
N/A | |
Completed |
NCT02840565 -
Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
|
Phase 1 | |
Completed |
NCT02441218 -
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
|
Phase 3 | |
Completed |
NCT00149409 -
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
|
Phase 2/Phase 3 | |
Terminated |
NCT05532046 -
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
|
Phase 1 | |
Recruiting |
NCT04984928 -
Readmission Risk of Patients With Heart Failure.
|
||
Completed |
NCT02814097 -
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
|
Phase 2 | |
Active, not recruiting |
NCT05560737 -
ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
|
||
Recruiting |
NCT03286127 -
Palliative Outcome Evaluation Muenster I
|