Global Congestive Heart Failure Registry

NCT03078166 | Completed

• 1 other identifier: 0812
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mortality, by cause

  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 Outcomes (1)

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

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Population Health Research Institute: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (1)

• Johansson I, Joseph P, Balasubramanian K, McMurray JJV, Lund LH, Ezekowitz JA, Kamath D, Alhabib K, Bayes-Genis A, Budaj A, Dans ALL, Dzudie A, Probstfield JL, Fox KAA, Karaye KM, Makubi A, Fukakusa B, Teo K, Temizhan A, Wittlinger T, Maggioni AP, Lanas F, Lopez-Jaramillo P, Silva-Cardoso J, Sliwa K, Dokainish H, Grinvalds A, McCready T, Yusuf S; G-CHF Investigators. Health-Related Quality of Life and Mortality in Heart Failure: The Global Congestive Heart Failure Study of 23 000 Patients From 40 Countries. Circulation. 2021 Jun;143(22):2129-2142. doi: 10.1161/CIRCULATIONAHA.120.050850. Epub 2021 Apr 28.

  PMID: 33906372 DERIVED

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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Salim Yusuf, DPhil, FRCPC, FRSC, O.C.

  Executive Director

  PRINCIPAL INVESTIGATOR

• Hisham Dokainish, M.D., FRCPC, FASE, FACC

  Internal PHRI Lead Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 13, 2017
• Study Start: December 20, 2016
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CA (1)