Heart FailureG-CHFNCT03078166
Global Congestive Heart Failure Registry
An observational study of Heart Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 25,000 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2016to 30 Jun 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients considered unreliable by the investigator concerning the requirements for follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Non-fatal major clinical events (both resulting in and not resulting in hospitalization)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start20 Dec 2016
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Salim Yusuf, DPhil, FRCPC, FRSC, O.C., Principal investigator, Executive DirectorHisham Dokainish, M.D., FRCPC, FASE, FACC, Principal investigator, Internal PHRI Lead Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078166
- Sponsor's protocol ID
- 0812
- Acronym
- G-CHF
- Status last verified
- Aug 2024
- First submitted
- 7 Mar 2017
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33906372
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Congestive Heart Failure Registry
- ClinicalTrials.gov ID
- NCT03078166
- Acronym / sponsor ID
- G-CHF / 0812
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients considered unreliable by the investigator concerning the requirements for follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Non-fatal major clinical events (both resulting in and not resulting in hospitalization)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 33906372Johansson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salim Yusuf, DPhil, FRCPC, FRSC, O.C. principal investigator
Executive Director
Hisham Dokainish, M.D., FRCPC, FASE, FACC principal investigator
Internal PHRI Lead Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality, by cause (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.