Contact information
Type
Scientific
Primary contact
Dr Denis Roy
ORCID ID
Contact details
Montreal Heart Institute
5000 Belanger Street East
Montreal
H1T 1C8
Canada
+1 514 376 3330 ext. 3652
d_roy@icm-mhi.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00597077
Protocol/serial number
MCT-41552
Study information
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
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.
Ethics approval
Comité d'éthique de la recherche et du développement des nouvelles technologies, Institut de Cardiologie de Montréal, 05/04/2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/10/2000
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1375
Participant 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
Recruitment start date
01/10/2000
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Canada, Israel, United States of America
Trial participating centre
Montreal Heart Institute
Montreal
H1T 1C8
Canada
Sponsor information
Organisation
Montreal Heart Institute (Canada)
Sponsor details
5000 est
rue Bélanger
Montréal
H1T 1C8
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41552)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2002 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/12360154
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18565859
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24622114
Publication citations
-
Protocol
Rationale and design of a study assessing treatment strategies of atrial fibrillation in patients with heart failure: the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial., Am. Heart J., 2002, 144, 4, 597-607.
-
Results
Roy D, Talajic M, Nattel S, Wyse DG, Dorian P, Lee KL, Bourassa MG, Arnold JM, Buxton AE, Camm AJ, Connolly SJ, Dubuc M, Ducharme A, Guerra PG, Hohnloser SH, Lambert J, Le Heuzey JY, O'Hara G, Pedersen OD, Rouleau JL, Singh BN, Stevenson LW, Stevenson WG, Thibault B, Waldo AL, , Rhythm control versus rate control for atrial fibrillation and heart failure., N. Engl. J. Med., 2008, 358, 25, 2667-2677, doi: 10.1056/NEJMoa0708789.
-
Results
Caldentey G, Khairy P, Roy D, Leduc H, Talajic M, Racine N, White M, O'Meara E, Guertin MC, Rouleau JL, Ducharme A, Prognostic value of the physical examination in patients with heart failure and atrial fibrillation: insights from the AF-CHF trial (atrial fibrillation and chronic heart failure)., JACC Heart Fail, 2014, 2, 1, 15-23, doi: 10.1016/j.jchf.2013.10.004.