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| Sponsor: | Royal Brompton & Harefield NHS Foundation Trust |
|---|---|
| Information provided by: | Royal Brompton & Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00878384 |
Purpose
It is still uncertain what the best treatment is for patients who have both atrial fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal treatment for patients with these two significant medical conditions. This will be performed by comparing two alternative strategies for AF management: catheter ablation (to restore normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal rhythm). After random assignment, the effect of each strategy will be assessed by looking for changes in exercise capacity, symptoms, heart pump function, and quality of life during 12 months of follow-up.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Heart Failure |
Drug: Medication to control ventricular rate in AF Procedure: Catheter Ablation for Persistent Atrial Fibrillation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomised Trial to Assess Catheter Ablation Versus Rate-Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Rate control: Active Comparator
Strategy of 'rate-control': acceptance of atrial fibrillation, and dose-adjusted drug therapy as needed to control ventricular rate.
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Drug: Medication to control ventricular rate in AF
Standard pharmacologic rate control. Current therapy will be adjusted to achieve rate-control targets of <80bpm and <110bpm on exercise (6 minute walk). Where necessary, additional medication will be given as per standard practice (digoxin or beta-blocker). Typical does: Digoxin 62.5-250mcg o.d. ; Bisoprolol 1.25-20mg o.d.; Carvedilol 3.125-50mg b.d. ; Nebivolol 1.25-10mg o.d.
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Catheter Ablation: Active Comparator
Strategy of 'rhythm control' by catheter ablation: patients will undergo catheter ablation with the intention of restoring sinus rhythm.
|
Procedure: Catheter Ablation for Persistent Atrial Fibrillation
Radiofrequency catheter ablation, which may include pulmonary vein isolation, atrial substrate modification, and/or linear ablation.
|
Currently available evidence suggests that occurrence of AF in patients with heart failure (HF) leads to a decline in exercise tolerance, worsened quality of life, increased hospitalisation, and in many studies an increase in mortality. These may be explained by the haemodynamic effects of AF i.e. reduction in functional cardiac output due to inappropriate heart rates, irregularity, and loss of atrial contraction, plus the risk of thromboembolism.
Evidence from large clinical studies has shown that patients with heart failure fare better if sinus rhythm can be restored, but on the contrary a 'rhythm control' strategy (as intention to treat) of cardioversion or antiarrhythmic drugs to achieve sinus rhythm has not been shown to be superior to the strategy of rate control. These apparently contradictory findings might be explained by the poor efficacy and side effects associated with current rhythm control strategies, or could reflect that AF is merely a passive marker of underlying disease severity. However, many studies would point to the former, and it might be hypothesised that the theoretical benefits of sinus rhythm could be seen for real in clinical practice if a superior rhythm-control strategy was used.
Catheter ablation, a relatively new treatment for atrial fibrillation, has been shown to be feasible in a non-randomised heart failure patient cohort, with markers suggesting improvement of cardiac function.
This prospective clinical trial will enrol HF patients on optimal therapy, with documented persistent AF, and compare the strategies of catheter-ablation and medical rate control in a 1:1 randomised fashion.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Contact: David G Jones, BSc, MBBS | 442073518742 | d.jones@rbht.nhs.uk |
| Contact: Tom Wong, MD, FESC | 442073518619 | tom.wong@imperial.ac.uk |
| United Kingdom | |
| Royal Brompton & Harefield NHS Trust | Recruiting |
| London, United Kingdom, SW3 6NP | |
| Sub-Investigator: David G Jones, BSc MBBS | |
| Principal Investigator: Tom Wong, MD FESC | |
| Principal Investigator: | Tom Wong, MD FESC | Royal Brompton & Harefield NHS Foundation Trust |
More Information
| Responsible Party: | Royal Brompton & Harefield NHS Trust ( Dr Tom Wong ) |
| Study ID Numbers: | 2008CI008B |
| Study First Received: | April 7, 2009 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00878384 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Atrial Fibrillation Heart Failure Heart Rate Control Catheter Ablation |
|
Heart Failure Pathologic Processes Heart Diseases |
Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |
