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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02595814
Other study ID # CRPORTHF
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 23, 2014
Est. completion date March 31, 2018

Study information

Verified date November 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.


Recruitment information / eligibility

Status Terminated
Enrollment 18805
Est. completion date March 31, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients at least 18 years old, or older for those countries where the adult age is above 18 years of age, hospitalized with a primary diagnosis of acute heart failure.

Exclusion Criteria:

1-Concomitant participation in any/a clinical trial with any investigational treatment (for any sponsor).

2. Use of investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Algeria Novartis Investigative Site Algiers
Algeria Novartis Investigative Site Algiers
Algeria Novartis Investigative Site Algiers
Algeria Novartis Investigative Site Oran
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires Ciudad De 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 Coronel Suarez Ciudad De Buenos Aires
Argentina Novartis Investigative Site Corrientes
Argentina Novartis Investigative Site Mendoza
Argentina Novartis Investigative Site Resistencia Chaco
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Salta
Australia Novartis Investigative Site Auchenflower Queensland
Australia Novartis Investigative Site Bedford Park
Australia Novartis Investigative Site Gosford New South Wales
Australia Novartis Investigative Site Greenslopes Queensland
Austria Novartis Investigative Site Eisenstadt
Austria Novartis Investigative Site Linz
Austria Novartis Investigative Site Moedling
Austria Novartis Investigative Site Vienna
Austria Novartis Investigative Site Wien
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Campinas SP
Brazil Novartis Investigative Site Curitiba PR
Brazil Novartis Investigative Site Curitiba
Brazil Novartis Investigative Site Fortaleza CE
Brazil Novartis Investigative Site Recife
Brazil Novartis Investigative Site Rio De Janeiro
Brazil Novartis Investigative Site Rio de Janeiro RJ
Brazil Novartis Investigative Site Sao Jose Do Rico Preto
Brazil Novartis Investigative Site Tatuí SP
Bulgaria Novartis Investigative Site Pleven
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Varna
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Halifax Nova Scotia
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Sainte-Foy Quebec
Canada Novartis Investigative Site Vancouver British Columbia
Chile Novartis Investigative Site Concepcion
Chile Novartis Investigative Site San Miguel Santiago
Chile Novartis Investigative Site Santiago
Chile Novartis Investigative Site Santiago
China Novartis Investigative Site Baotou Inner Mongolia
China Novartis Investigative Site Beijing Beijing
China Novartis Investigative Site Beijing Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Changchun Jilin
China Novartis Investigative Site Changsha Hunan
China Novartis Investigative Site Changsha Hunan
China Novartis Investigative Site Dalian Liaoning
China Novartis Investigative Site Fuzhou Fujian
China Novartis Investigative Site Guang Zhou
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China Novartis Investigative Site Hangzhou
China Novartis Investigative Site Jinan
China Novartis Investigative Site Luoyang
China Novartis Investigative Site Shanghai
China Novartis Investigative Site Shijiazhuang Hebei
China Novartis Investigative Site Taiyuan
China Novartis Investigative Site Urumqi
China Novartis Investigative Site Urumqi
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China Novartis Investigative Site Xiamen
China Novartis Investigative Site Yangzhou
China Novartis Investigative Site Zhengzhou
China Novartis Investigative Site Zhengzhou
Colombia Novartis Investigative Site Armenia
Colombia Novartis Investigative Site Barranquilla Atlantico
Colombia Novartis Investigative Site Barranquilla Atlántico
Colombia Novartis Investigative Site Bogota
Colombia Novartis Investigative Site Bogotá
Colombia Novartis Investigative Site Bogotá
Colombia Novartis Investigative Site Bogotá Cundinamarca
Colombia Novartis Investigative Site Bucaramanga Santander
Colombia Novartis Investigative Site Cali
Colombia Novartis Investigative Site Medellin Antioquia
Colombia Novartis Investigative Site Medellin Antioquia
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Ecuador Novartis Investigative Site Quito Pichincha
Egypt Novartis Investigative Site Alexandria
Egypt Novartis Investigative Site Cairo
Egypt Novartis Investigative Site Cairo
Egypt Novartis Investigative Site El Menia, Upper Egypt
Egypt Novartis Investigative Site Suez Canal Region
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bonn
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Goettingen
Germany Novartis Investigative Site Halle
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Germany Novartis Investigative Site Heidelberg
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Germany Novartis Investigative Site Lubeck
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Greece Novartis Investigative Site Athens GR
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Greece Novartis Investigative Site Athens GR
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
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Greece Novartis Investigative Site Glyfada
Greece Novartis Investigative Site Ioannina
Greece Novartis Investigative Site Piraeus
Greece Novartis Investigative Site Thessaloniki
Greece Novartis Investigative Site Thessaloniki GR
Guatemala Novartis Investigative Site Guatemala
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India Novartis Investigative Site Ahmedabad Gujarat
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India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Chennai Tamil NADU
India Novartis Investigative Site Gurgaon Haryana
India Novartis Investigative Site Hyderabad Telangana
India Novartis Investigative Site Hyderabad Telangana
India Novartis Investigative Site India
India Novartis Investigative Site Kolkata West Bengal
India Novartis Investigative Site Kolkata West Bengal
India Novartis Investigative Site Ludhiana Punjab
India Novartis Investigative Site Ludhiana Punjab
India Novartis Investigative Site Manipal Karnataka
India Novartis Investigative Site Mumbai
India Novartis Investigative Site Nagpur Maharashtra
India Novartis Investigative Site New Delhi Delhi
India Novartis Investigative Site New Delhi Delhi
India Novartis Investigative Site New Delhi Delhi
India Novartis Investigative Site New Delhi
India Novartis Investigative Site New Delhi
India Novartis Investigative Site Panaji Goa
India Novartis Investigative Site Pune Maharashtra
India Novartis Investigative Site Pune Maharashtra
India Novartis Investigative Site Vadodara Gujarat
Indonesia Novartis Investigative Site Bandung West Java
Indonesia Novartis Investigative Site Bekasi West Java
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Indonesia Novartis Investigative Site Medan North Sumatera
Indonesia Novartis Investigative Site Padang Sumatera Barat
Indonesia Novartis Investigative Site South Jakarta DKI Jakarta
Indonesia Novartis Investigative Site Surabaya East Java
Indonesia Novartis Investigative Site Tangerang Banten
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Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Kfar-Saba
Israel Novartis Investigative Site Nazareth
Israel Novartis Investigative Site Sefad
Japan Novartis Investigative Site Chiyoda-ku Tokyo
Japan Novartis Investigative Site Hirakata-City Osaka
Japan Novartis Investigative Site Kita-ku Okayama
Japan Novartis Investigative Site Kitakyushu-city Fukuoka
Japan Novartis Investigative Site Kure Hiroshima
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Japan Novartis Investigative Site Sakaide-city Kagawa
Jordan Novartis Investigative Site Amman
Jordan Novartis Investigative Site Amman
Jordan Novartis Investigative Site Amman
Jordan Novartis Investigative Site Amman
Jordan Novartis Investigative Site Irbid
Korea, Republic of Novartis Investigative Site Busan
Korea, Republic of Novartis Investigative Site Cheongju-si Chungcheongbuk-do
Korea, Republic of Novartis Investigative Site Daejeon Korea
Korea, Republic of Novartis Investigative Site Gyeonggi-do Bucheon-si
Korea, Republic of Novartis Investigative Site Incheon
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 Suwon
Korea, Republic of Novartis Investigative Site Taegu
Korea, Republic of Novartis Investigative Site Wonju Gangwon-Do
Lebanon Novartis Investigative Site Beirut
Lebanon Novartis Investigative Site Beirut
Lebanon Novartis Investigative Site Beirut
Lebanon Novartis Investigative Site El Chouf LBN
Lebanon Novartis Investigative Site Jbeil
Lebanon Novartis Investigative Site Saida
Malaysia Novartis Investigative Site Alor Setar Kedah
Malaysia Novartis Investigative Site Johor Bahru
Malaysia Novartis Investigative Site Kota Bahru Kelantan
Malaysia Novartis Investigative Site Kuala Lumpur
Malaysia Novartis Investigative Site Pulau Pinang Penang
Mexico Novartis Investigative Site Aguascalientes
Mexico Novartis Investigative Site Culiacán Sinaloa SN
Mexico Novartis Investigative Site Mexico Distrito Federal
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Mexico Novartis Investigative Site San Luis Potosi
Mexico Novartis Investigative Site San Luis Potosi
Mexico Novartis Investigative Site Xalapa
Mexico Novartis Investigative Site Xalapa
Morocco Novartis Investigative Site Casablanca
Morocco Novartis Investigative Site Marrakech
Morocco Novartis Investigative Site Rabat
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Groningen
Netherlands Novartis Investigative Site Leiderdorp
Netherlands Novartis Investigative Site Sneek
Netherlands Novartis Investigative Site Venlo
Netherlands Novartis Investigative Site Zwolle
Norway Novartis Investigative Site Hønefoss
Norway Novartis Investigative Site Oslo
Norway Novartis Investigative Site Skien
Panama Novartis Investigative Site Panama
Panama Novartis Investigative Site Panama City
Panama Novartis Investigative Site San Jose De David Panamá
Philippines Novartis Investigative Site Angeles City Pampanga
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Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Buzau
Romania Novartis Investigative Site Cluj Napoca
Romania Novartis Investigative Site Cluj-Napoca
Romania Novartis Investigative Site Focsani
Romania Novartis Investigative Site Lasi
Romania Novartis Investigative Site Timisoara
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Kemerovo
Russian Federation Novartis Investigative Site Krasnodar
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Novosibirsk
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 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 Stavropol
Russian Federation Novartis Investigative Site Tyumen
Russian Federation Novartis Investigative Site Ulyanovsk
Russian Federation Novartis Investigative Site Vladivostok
Russian Federation Novartis Investigative Site Volgograd
Saudi Arabia Novartis Investigative Site Al Ahsa
Saudi Arabia Novartis Investigative Site Dammam
Saudi Arabia Novartis Investigative Site Dammam
Saudi Arabia Novartis Investigative Site Khamis Mushayt
Saudi Arabia Novartis Investigative Site Riyadh
South Africa Novartis Investigative Site Bloemfontein
South Africa Novartis Investigative Site Cape Town
South Africa Novartis Investigative Site Cape Town
South Africa Novartis Investigative Site Durban Kwa-Zulu Natal
South Africa Novartis Investigative Site Rivonia
Spain Novartis Investigative Site Alicante Comunidad Valenciana
Spain Novartis Investigative Site Barakaldo Pais Vasco
Spain Novartis Investigative Site Barcelona
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Spain Novartis Investigative Site Cordoba
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Spain Novartis Investigative Site Leon
Spain Novartis Investigative Site Majadahonda Madrid
Spain Novartis Investigative Site Mallorca Islas Baleares
Spain Novartis Investigative Site Merida Extremadura
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Spain Novartis Investigative Site Tarragona Catalunya
Sweden Novartis Investigative Site Göteborg
Sweden Novartis Investigative Site Helsingborg
Sweden Novartis Investigative Site Karlshamn
Sweden Novartis Investigative Site Linkoping
Sweden Novartis Investigative Site Malmö
Sweden Novartis Investigative Site Trollhättan
Switzerland Novartis Investigative Site Basel
Switzerland Novartis Investigative Site Bruderholz
Switzerland Novartis Investigative Site Zuerich
Taiwan Novartis Investigative Site Lin-Kou
Taiwan Novartis Investigative Site Taichung
Taiwan Novartis Investigative Site Tainan
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Chiang Mai
Thailand Novartis Investigative Site Khon Kaen THA
Thailand Novartis Investigative Site Muang
Thailand Novartis Investigative Site Muang
Thailand Novartis Investigative Site Muang
Tunisia Novartis Investigative Site Monastir
Tunisia Novartis Investigative Site Sousse
Tunisia Novartis Investigative Site Tunis
Tunisia Novartis Investigative Site Tunis
Tunisia Novartis Investigative Site Tunis
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Bursa
Turkey Novartis Investigative Site Bursa
Turkey Novartis Investigative Site Diskapi / Ankara
Turkey Novartis Investigative Site Haydarpasa/Istanbul
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Meselik / Eskisehir
Turkey Novartis Investigative Site Pendik / Istanbul
Turkey Novartis Investigative Site Sivas
United Arab Emirates Novartis Investigative Site Abu Dhabi
United Arab Emirates Novartis Investigative Site Al Ain
United Arab Emirates Novartis Investigative Site Dubai
United Arab Emirates Novartis Investigative Site Dubai
United Kingdom Novartis Investigative Site Bradford West Yorkshire
United Kingdom Novartis Investigative Site Chesterfield Yorkshire
United Kingdom Novartis Investigative Site Chesterfield
United Kingdom Novartis Investigative Site Edgbaston Birmingham
United Kingdom Novartis Investigative Site Herts Yorkshire
United Kingdom Novartis Investigative Site Stockton on Tees Cleveland
United Kingdom Novartis Investigative Site Telford
United Kingdom Novartis Investigative Site Uxbridge
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United Kingdom Novartis Investigative Site York
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United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Detroit Michigan
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United States Novartis Investigative Site Indianapolis Indiana
United States Novartis Investigative Site Jackson Mississippi
United States Novartis Investigative Site Kansas City Kansas
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site New Orleans Louisiana
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United States Novartis Investigative Site New York New York
United States Novartis Investigative Site San Diego California
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Vietnam Novartis Investigative Site Ho Chi Minh
Vietnam Novartis Investigative Site Ho Chi Minh City
Vietnam Novartis Investigative Site Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Algeria,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Ecuador,  Egypt,  Germany,  Greece,  Guatemala,  India,  Indonesia,  Israel,  Japan,  Jordan,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Morocco,  Netherlands,  Norway,  Panama,  Philippines,  Romania,  Russian Federation,  Saudi Arabia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Tunisia,  Turkey,  United Arab Emirates,  United Kingdom, 

References & Publications (1)

Filippatos G, Khan SS, Ambrosy AP, Cleland JG, Collins SP, Lam CS, Angermann CE, Ertl G, Dahlström U, Hu D, Dickstein K, Perrone SV, Ghadanfar M, Bermann G, Noe A, Schweizer A, Maier T, Gheorghiade M. International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF): rationale for and design of a global registry. Eur J Heart Fail. 2015 May;17(5):527-33. doi: 10.1002/ejhf.262. Epub 2015 Mar 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with different characteristics of heart faliure (HF) at hospitalization From admission to discharge of the patient's index hospitalization (minimum 24 hours)
Primary Percentage of patients who die during the index hospitalization From admission to discharge of the patient's index hospitalization (minimum 24 hours)
Primary Percentage of patients who die during the follow-up period post-discharge up to 3 years
Primary Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular) up to 3 years
Primary Number of patients with different characteristics of post-discharge patient management up to 3 years
Primary Healthcare Resource Utilization assessed by number of patients with re-hospitalizations up to 3 years
Secondary Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires up to 3 years
Secondary Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires up to 3 years
Secondary Correlation ratio between practice patterns and outcomes up to 3 years
See also
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