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.
Brief Title
Global Congestive Heart Failure Registry
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03078166
Org Class
Other
Org Full Name
Hamilton Health Sciences Corporation
Org Study Id
0812
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Global Congestive Heart Failure Registry
Primary Outcomes
Outcome Description
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.
Outcome Measure
Mortality, by cause
Outcome Time Frame
2 years
Secondary Outcomes
Outcome Time Frame
2 years
Outcome Measure
Non-fatal major clinical events (both resulting in and not resulting in hospitalization)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sandhya Murthy
Investigator Email
smurthy@montefiore.org
Investigator Phone
718-904-3507