G-CHF: Global Congestive Heart Failure Registry

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03078166
Collaborator
Population Health Research Institute (Other)
25,000
1
84.3
296.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    25000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Global Congestive Heart Failure Registry
    Actual Study Start Date :
    Dec 20, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Non-fatal major clinical events (both resulting in and not resulting in hospitalization) [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamilton General Hospital Hamilton Ontario Canada L8L2X2

    Sponsors and Collaborators

    • Hamilton Health Sciences Corporation
    • Population Health Research Institute

    Investigators

    • Principal Investigator: Salim Yusuf, DPhil, FRCPC, FRSC, O.C., Executive Director
    • Principal Investigator: Hisham Dokainish, M.D., FRCPC, FASE, FACC, Internal PHRI Lead Investigator

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hamilton Health Sciences Corporation
    ClinicalTrials.gov Identifier:
    NCT03078166
    Other Study ID Numbers:
    • 0812
    First Posted:
    Mar 13, 2017
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hamilton Health Sciences Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2021