Atrial fibrillation and congestive heart failure (AF-CHF) study
| ISRCTN | ISRCTN84858671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84858671 |
| ClinicalTrials.gov number | NCT00597077 |
| Secondary identifying numbers | MCT-41552 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Denis Roy
Scientific
Scientific
Montreal Heart Institute
5000 Belanger Street East
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 ext. 3652 |
|---|---|
| d_roy@icm-mhi.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Restoring and maintaining sinus rhythm versus rate control treatment strategy to reduce cardiovascular mortality in patients with atrial fibrillation and congestive heart failure: a randomised controlled trial |
| Study acronym | AF-CHF |
| Study objectives | Restoring and maintaining sinus rhythm reduces cardiovascular mortality (instead of 'improves survival') compared to a rate control treatment strategy in patients with AF and CHF. |
| Ethics approval(s) | Comité d'éthique de la recherche et du développement des nouvelles technologies, Institut de Cardiologie de Montréal, 05/04/2001 |
| Health condition(s) or problem(s) studied | Atrial fibrillation, congestive heart failure |
| Intervention | 1. Restoring and maintaining sinus rhythm compared to a rate control treatment strategy 2. Resting electrocardiogram (ECG) and a 6-minute walk test 3. Electrical cardioversion 4. Pacemaker implantation Trial details received: 12 Sept 2005 |
| Intervention type | Other |
| Primary outcome measure | Cardiovascular death during follow-up which will end for all patients on 30/06/2007 |
| Secondary outcome measures | 1. Total mortality 2. Stroke 3. Hospitalisation 4. Quality of life 5. Cost of therapy 6. Composite endpoint of cardiovascular death and stroke |
| Overall study start date | 01/10/2000 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1375 |
| Key inclusion criteria | 1. Symptomatic CHF (New York Heart Association [NYHA] class II - IV) at some time during the 6 months before randomisation (instead of '3 months') 2. Aged greater than or equal to 50 years old, either sex 3. Left ventricular ejection fraction less than or equal to 35% 4. History of significant atrial fibrillation 5. Patients must be eligible for long term treatment with either treatment strategy of AF 6. AF is known to be present and uninterrupted for greater than 12 months prior to randomisation |
| Key exclusion criteria | 1. Reverse cause of AF such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication 2. Unstable (pulmonary oedema, hypoperfusion) decompensated CHF 3. Antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or indications 4. Atrial fibrillation occurring and not persisting beyond 10 days after surgery or myocardial infarction 5. Second or third degree AV block, sinus pause greater than 3 seconds, resting heart rate less than 50 bpm without a permanent pacemaker 6. History of drug-induced or congenital long QT syndrome 7. Reversible causes of CHF such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy 8. Prior AV nodal ablation or maze surgery 9. Probable cardiac transplantation in the next 6 months 10. Chronic renal failure requiring dialysis 11. Women of childbearing potential and not on a reliable method of birth control |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Canada
- Israel
- United States of America
Study participating centre
Montreal Heart Institute
Montreal
H1T 1C8
Canada
H1T 1C8
Canada
Sponsor information
Montreal Heart Institute (Canada)
Research organisation
Research organisation
5000 est, rue Bélanger
Montréal
H1T 1C8
Canada
| Website | http://www.icm-mhi.org |
|---|---|
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41552)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2002 | Yes | No | |
| Results article | results | 19/06/2008 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No |
