Atrial Fibrillation and Congestive Heart Failure Trial

NCT00597077 | Completed Phase 4 DMC

• 2 other identifiers: 41552ISRCTN84858671
• Study Type: interventional
• Target: 1,376
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a clinical syndrome where the heart is unable to pump enough blood to satisfy the organism's metabolic needs. Heart failure has become a major clinical and public health problem with approximately 300,000 Canadians being affected. Atrial fibrillation is a rhythm disorder in which the upper chambers of the heart (the atria) are paralyzed by continuous electrical activity. Some of the continuous chaotic electrical activity in the atria travels to the lower cavities of the heart (the ventricles) causing then to beat irregularly and very rapidly. It is the most frequent cardiac arrhythmia, affecting 5% of individuals 65 years and older and it is associated with an increased risk of stroke. Both conditions (heart failure and atrial fibrillation) often co-exist in the same patient. Heart failure promotes atrial fibrillation and atrial fibrillation aggravates heart failure. The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is investigating whether preservation of normal cardiac rhythm influences mortality and morbidity. The AF-CHF study began in 2001 and 1,378 patients have been enrolled from 123 participating centres, in North America, South America, Europe, and Israel. The results of this trial which are expected in October 2007, will improve decision-making for the physician and will provide useful information to healthcare organizations responsible for the care of heart failure patients.

Conditions

Atrial Fibrillation; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• cardiovascular death

  Minimum of 2 years and a maximum of 6 years

Secondary Outcomes (8)

• Total mortality

  Minimun of 2 years and a maxiumum of 6 years

• Stroke

  Minimum of 2 years and a maximum of 6 years

• Worsening CHF

  Minimum of 2 years and maximum of 6 years

• Hospitalization

  Minumum of 2 years and maximum of 6 years

• Composite endpoint of CV death and worsening CHF

  Minimum of 2 years and a maximum of 6 years

Study Arms (2)

Rate control

ACTIVE COMPARATOR

Other: Rate vs rhythm control strategies for atrial fibrillation

Rhythm control

ACTIVE COMPARATOR

Other: Rate vs rhythm control strategies in atrial fibrillation

Interventions

Rate vs rhythm control strategies for atrial fibrillation OTHER

Rate vs rhythm control strategies for atrial fibrillation

Rate control

Rate vs rhythm control strategies in atrial fibrillation OTHER

rate vs rhythm control strategies in atrial fibrillation

Rhythm control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction \</=35% as measured by nuclear imaging, echocardiography, or cardiac angiography within 6 months preceding enrollment. If the patient has had a myocardial infarction or heart surgery during this period, the ejection fraction must be remeasured.
• Symptomatic CHF (NYHA class II-IV) at some time during the 6 months before randomization, despite therapy with an ACE inhibitor (however, patients who do not tolerate an ACE inhibitor are eligible). Asymptomatic patients (NYHA class I) with either a prior hospitalization for CHF during the 6 months before randomization or with a left ventricular ejection fraction of \</=25% are also eligible.
• History of significant AF, defined as either:
• one episode lasting \>/=6 hours (duration of AF will be determined by history), within the past 6 months with electrocardiographic confirmation; or
• an episode lasting \>/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for AF.
• In the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of AF.

You may not qualify if:

• AF is known to be present and uninterrupted for more than 12 months prior to randomization. However, if such a patient is cardioverted and maintained in sinus rhythm for \>/=24 hours, he or she becomes eligible.
• Reversible cause of AF such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication.
• AF occurring and not persisting beyond 10 days of surgery or myocardial infarction.
• Reversible cause of CHF such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy.
• Decompensated CHF within 48 hours of randomization.
• Antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications.
• More than 7 days of amiodarone therapy within the last month prior to randomization.
• Second or third degree AV block, sinus pause \>3 seconds, resting heart rate \<50 bpm without a permanent pacemaker.
• History of drug-induced Torsades de Pointes or congenital long QT syndrome.
• Prior AV nodal ablation or Maze surgery.
• Probable cardiac transplantation in the next 6 months.
• Chronic renal failure requiring dialysis.
• Women of child-bearing potential and not on a reliable method of birth control.
• Geographic or social factors, drug or alcohol abuse making follow-up or compliance difficult.
• Other noncardiovascular medical condition (such as cancer) making 1 year survival unlikely.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, h1s2j2, Canada

Location

Related Publications (3)

• O'Meara E, Khairy P, Blanchet MC, de Denus S, Pedersen OD, Levesque S, Talajic M, Ducharme A, White M, Racine N, Rouleau JL, Tardif JC, Roy D; AF-CHF investigators. Mineralocorticoid receptor antagonists and cardiovascular mortality in patients with atrial fibrillation and left ventricular dysfunction: insights from the Atrial Fibrillation and Congestive Heart Failure Trial. Circ Heart Fail. 2012 Sep 1;5(5):586-93. doi: 10.1161/CIRCHEARTFAILURE.111.965160. Epub 2012 Jul 12.

  PMID: 22798522 DERIVED

• Frasure-Smith N, Lesperance F, Habra M, Talajic M, Khairy P, Dorian P, Roy D; Atrial Fibrillation and Congestive Heart Failure Investigators. Elevated depression symptoms predict long-term cardiovascular mortality in patients with atrial fibrillation and heart failure. Circulation. 2009 Jul 14;120(2):134-40, 3p following 140. doi: 10.1161/CIRCULATIONAHA.109.851675. Epub 2009 Jun 29.

  PMID: 19564557 DERIVED

• 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; Atrial Fibrillation and Congestive Heart Failure Investigators. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med. 2008 Jun 19;358(25):2667-77. doi: 10.1056/NEJMoa0708789.

  PMID: 18565859 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denis Roy

  Montreal Heart Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: April 1, 2001
• Primary Completion: June 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 8, 2008

Record last verified: 2008-01

Locations

CA (1)