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Global Non-interventional Heart Failure Disease Registry

International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02595814
Acronym
REPORT-HF
Enrollment
18805
Registered
2015-11-03
Start date
2014-07-23
Completion date
2018-03-31
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Keywords

Registry, Heart failure, Hospitalized, Global, Morbidity, Mortality, Quality of life, AHF

Brief 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.

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Healthcare Resource Utilization assessed by number of patients with re-hospitalizationsup to 3 years
Percentage of patients who die during the follow-up period post-dischargeup to 3 years
Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular)up to 3 years
Number of patients with different characteristics of post-discharge patient managementup to 3 years
Number of patients with different characteristics of heart faliure (HF) at hospitalizationFrom admission to discharge of the patient's index hospitalization (minimum 24 hours)
Percentage of patients who die during the index hospitalizationFrom admission to discharge of the patient's index hospitalization (minimum 24 hours)

Secondary

MeasureTime frame
Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnairesup to 3 years
Correlation ratio between practice patterns and outcomesup to 3 years
Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnairesup to 3 years

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026