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| [ ...Back to search results ] | [ Print-friendly version ] |
| Atrial fibrillation and congestive heart failure (AF-CHF) study |
| ISRCTN | ISRCTN84858671 |
| ClinicalTrials.gov identifier | NCT00597077 |
| Public title | Atrial fibrillation and congestive heart failure (AF-CHF) study |
| 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 |
| Acronym | AF-CHF |
| Serial number at source | MCT-41552 |
| Study hypothesis | 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Comité d'éthique de la recherche et du développement des nouvelles technologies, Institut de Cardiologie de Montréal gave approval on the 5th April 2001 |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada, Israel, United States of America, Europe, International |
| Disease/condition/study domain | Atrial fibrillation, congestive heart failure |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2000 |
| Anticipated end date | 30/09/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1375 |
| Interventions |
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 |
| Primary outcome measure(s) | Cardiovascular death during follow up which will end for all patients on 30th June 2007 |
| Secondary outcome measure(s) |
1. Total Mortality
2. Stroke 3. Hospitalisation 4. Quality of life 5. Cost of therapy 6. Composite endpoint of cardiovascular death and stroke |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41552) |
| Trial website | |
| Publications |
1. 2002 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12360154
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18565859 |
| Contact name | Dr Denis Roy |
| Address |
Montreal Heart Institute
5000 Belanger Street East |
| City/town | Montreal |
| Zip/Postcode | H1T 1C8 |
| Country | Canada |
| Tel | +1 514 376 3330 ext. 3652 |
| Fax | +1 514 593 2581 |
| d_roy@icm-mhi.com | |
| Sponsor | Montreal Heart Institute (Canada) |
| Address | 5000 est, rue Bélanger |
| City/town | Montréal |
| Zip/Postcode | H1T 1C8 |
| Country | Canada |
| Sponsor website: | http://www.icm-mhi.org |
| Date applied | 26/09/2005 |
| Last edited | 30/08/2011 |
| Date ISRCTN assigned | 26/09/2005 |
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