Clinical trial NCT03078166: Global Congestive Heart Failure Registry
Official title: Global Congestive Heart Failure Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
First posted: 2017-03-13
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Mortality, by cause
timeFrame: 2 years
Secondary outcomes:
measure: Non-fatal major clinical events (both resulting in and not resulting in hospitalization)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Executive Director
name: Salim Yusuf, DPhil, FRCPC, FRSC, O.C.
role: PRINCIPAL_INVESTIGATOR
affiliation: Internal PHRI Lead Investigator
name: Hisham Dokainish, M.D., FRCPC, FASE, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.