Global Congestive Heart Failure Registry

Completed

• Conditions: Heart Failure

• Registration Number: NCT03078166
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Heart failure (HF) is a major health problem worldwide but there is no global HF study that documents demographics, socioeconomic and clinical factors, diagnostic and management patterns, etiology, biomarkers, co-morbidities, treatments, quality of life, barriers to care and outcomes in all parts of the world. Such knowledge is essential in the prevention and treatment of this global disease. The Global Congestive Heart Failure Registry (G-CHF) is a global registry of approximately 20,000-25,000 HF patients enrolled over approximately 5 years to study these risks and causes of HF.

Detailed Description

The G-CHF Registry is a prospective global cohort study of approximately 20,000-25,000 HF patients enrolled over approximately 5 years. Baseline data will be obtained on demographic and socioeconomic data, clinical and laboratory variables, co-morbidities, biomarkers, echocardiography, HF causes, medication use, management patterns, quality of life, and health systems. Six-month, 12-month, 18-month and 24-month follow-up data will be obtained to document patient outcomes and factors associated with outcomes.

A sub-study of approximately 4000 patients (a subset of the main study population) will be performed to measure frailty, cognitive and lung function, mental health, medication adherence, patient-reported barriers to care, dietary assessment, and collection of blood and urine samples for central storage and analysis.

Study Timeline

• Study Start: 2016-12-20
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• Patients ≥ 18 years of age with a clinical diagnosis of HF seen in outpatient clinics or inpatient hospital wards of the participating centres.
• Written informed consent

Exclusion Criteria

• Patients considered unreliable by the investigator concerning the requirements for follow-up visits.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality, by cause	2 years	The main objective of G-CHF is to obtain reliable estimates of mortality and other non-fatal clinical outcomes in HF patients overall and in 6 global regions. Factors associated with outcomes will be explored. All outcome events will be recorded and summarized individually as rates and proportions, with two-sided confidence intervals calculated.

Secondary Outcome Measures

Name	Time	Method
Non-fatal major clinical events (both resulting in and not resulting in hospitalization)	2 years

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada