Acute Heart Failure Clinical Trial
— REPORT-HFOfficial title:
International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure
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 |
Verified date | November 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
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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 | |
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Chile | Novartis Investigative Site | Santiago | |
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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 | |
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Jordan | Novartis Investigative Site | Irbid | |
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Korea, Republic of | Novartis Investigative Site | Daejeon | Korea |
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Korea, Republic of | Novartis Investigative Site | Incheon | |
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United States | Novartis Investigative Site | Stony Brook | New York |
Vietnam | Novartis Investigative Site | Ho Chi Minh | |
Vietnam | Novartis Investigative Site | Ho Chi Minh City | |
Vietnam | Novartis Investigative Site | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
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,
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
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 |
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