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Sponsored by: |
Montreal Heart Institute |
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Information provided by: | Montreal Heart Institute |
ClinicalTrials.gov Identifier: | NCT00597077 |
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.
Condition | Intervention | Phase |
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Atrial Fibrillation Congestive Heart Failure |
Other: Rate vs rhythm control strategies for atrial fibrillation Other: Rate vs rhythm control strategies in atrial fibrillation |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Atrial Fibrillation and Congestive Heart Failure (AF-CHF)Trial |
Enrollment: | 1376 |
Study Start Date: | April 2001 |
Study Completion Date: | October 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Rate control: Active Comparator |
Other: Rate vs rhythm control strategies for atrial fibrillation
Rate vs rhythm control strategies for atrial fibrillation
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Rhythm control: Active Comparator |
Other: Rate vs rhythm control strategies in atrial fibrillation
rate vs rhythm control strategies in atrial fibrillation
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Congestive heart failure (CHF) and atrial fibrillation (AF) are two important and growing problems in medicine and cardiology. Both conditions often co-exist and complicate each other's management. Two therapeutic strategies are available for patients with AF and CHF: the first aims at restoring and maintaining sinus rhythm, whereas, the second focuses exclusively on optimizing ventricular rate. The primary objective of the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is to compare these two widely-used treatment strategies with respect to cardiovascular mortality. Hypothesis: Restoring and maintaining sinus rhythm reduces cardiovascular mortality compared to a rate control treatment strategy in patients with AF and CHF. Rationale: Despite new therapeutic interventions, the prognosis of heart failure patients remains grim with 5-year survival rates usually less than 50%. In most recent, large CHF trials, AF has been reported to be independently associated with increased mortality. Non-randomized observations also suggest that patients with AF in the setting of CHF have a greater tendency to revert to sinus rhythm during amiodarone therapy or with newer class III antiarrhythmic agents and that those who maintain a normal rhythm have a better prognosis. There is a need to determine whether a treatment strategy that attempts to maintain sinus rhythm will have a beneficial impact on cardiovascular mortality in CHF patients. This hypothesis has never been tested in a prospective, controlled, adequately-powered randomized trial. Research Plan: AF-CHF is a prospective, multicentre clinical trial (100 centres in Canada, the USA, and Europe), that will randomize 1,450 NYHA class II-IV CHF patients with left ventricular ejection fraction
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of significant AF, defined as either:
Exclusion Criteria:
Responsible Party: | Montreal Heart Institute ( Denis Roy, MD ) |
Study ID Numbers: | 41552, ISRCTN84858671 |
Study First Received: | January 8, 2008 |
Last Updated: | February 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00597077 History of Changes |
Health Authority: | Canada: Canadian Institutes of Health Research |
Heart Failure Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Heart Failure Pathologic Processes Heart Diseases |
Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |