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Global Congestive Heart Failure Registry (G-CHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078166
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Study Description
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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
Heart Failure

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Global Congestive Heart Failure Registry
Actual Study Start Date : December 20, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Non-fatal major clinical events (both resulting in and not resulting in hospitalization) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Approximately 4000 patients (a subset of the main G-CHF study population) will have blood and urine collected. Anonymized specimens will be sent to a central laboratory in Hamilton, Ontario, Canada for further storage and analysis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078166


Locations
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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Population Health Research Institute
Investigators
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Principal Investigator: Salim Yusuf, DPhil, FRCPC, FRSC, O.C. Executive Director
Principal Investigator: Hisham Dokainish, M.D., FRCPC, FASE, FACC Internal PHRI Lead Investigator
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03078166    
Other Study ID Numbers: 0812
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Cardiac Failure
Congestive Heart Failure
Heart Decompensation
Heart Failure, Congestive
Heart Failure, Left-Sided
Heart Failure, Right-Sided
 Left-Sided Heart Failure
Myocardial Failure
Right-Sided Heart Failure
Outcomes
Co-morbidities
Biomarkers
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases