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NCT Number: NCT03078166

Global Congestive Heart Failure Registry

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Non-fatal major clinical events (both resulting in and not resulting in hospitalization)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Population Health Research Institute

Registry information

Acronym: G-CHF

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2017
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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