Global Congestive Heart Failure Registry (G-CHF)

February 27, 2023 updated by: Hamilton Health Sciences Corporation
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HF will be recruited from approximately 200-300 centers in North America, South America, Europe, Africa, Asia, the Middle East, and Australia over approximately 5 years (approximately 4,000-5,000 patients per year), resulting in an initial sample estimate of approximately 20,000-25,000 patients. In each country, approximately 2/3 of patients will be recruited from the outpatient clinic setting (chronic HF) and 1/3 from the hospital inpatient setting (acute HF or acute exacerbation of chronic HF). At least one site in each country will be rural.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality, by cause
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-fatal major clinical events (both resulting in and not resulting in hospitalization)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2016

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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