Global Non-interventional Heart Failure Disease Registry

Terminated

• Conditions: Acute Heart Failure

• Registration Number: NCT02595814
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-23
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18805

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients who die during the index hospitalization	From admission to discharge of the patient's index hospitalization (minimum 24 hours)
Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular)	up to 3 years
Percentage of patients who die during the follow-up period post-discharge	up to 3 years
Healthcare Resource Utilization assessed by number of patients with re-hospitalizations	up to 3 years
Number of patients with different characteristics of post-discharge patient management	up to 3 years
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)

Secondary Outcome Measures

Name	Time	Method
Correlation ratio between practice patterns and outcomes	up 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) questionnaires	up to 3 years
Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires	up to 3 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam