Atrial fibrillation and congestive heart failure (AF-CHF) study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84858671

Enrollment

1375

Registered

2005-09-26

Start date

2000-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, congestive heart failure Circulatory System Heart failure

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 implantatio

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Cardiovascular death during follow-up which will end for all patients on 30/06/2007	—

Secondary

Measure	Time frame
1. Total mortality 2. Stroke 3. Hospitalisation 4. Quality of life 5. Cost of therapy 6. Composite endpoint of cardiovascular death and stroke	—

Countries

Canada, Israel, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026