Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.icm-mhi.org

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes