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Prevention of Atrial Fibrillation With ARB After Catheter Ablation
This study is not yet open for participant recruitment.
Verified by Queen Elizabeth II Health Sciences Centre, February 2007
First Received: February 7, 2007   Last Updated: February 20, 2007   History of Changes
Sponsored by: Queen Elizabeth II Health Sciences Centre
Information provided by: Queen Elizabeth II Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00438113
  Purpose

Atrial fibrillation (AF) is a very common arrhythmia causing many symptoms resulting in numerous hospitalizations. Catheter ablation is a technique that has evolved significantly to improve symptomatic recurrences, but does not offer a 100% cure rate. We hypothesize that the use of angiotensin receptor blockers (ARBs) will reduce the rate of recurrent AF after catheter ablation for AF or atrial flutter. We plan a randomized clinical trial of an ARB versus placebo to investigate this. The primary outcome will be time to recurrent AF.


Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Drug: Angiotensin Receptor Blocker (valsartan)
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Randomized Clinical Trial of Prevention of Post Ablation Recurrence of Atrial Fibrillation With Angiotensin Receptor Blockers

Resource links provided by NLM:


Further study details as provided by Queen Elizabeth II Health Sciences Centre:

Primary Outcome Measures:
  • Time to recurrent Atrial fibrillation

Secondary Outcome Measures:
  • Recurrence of AF at one year

Estimated Enrollment: 310
Study Start Date: July 2007
Estimated Study Completion Date: July 2011
Detailed Description:

Background: Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with significant morbidity, necessitating treatment.

Radiofrequency ablation for atrial fibrillation/flutter has evolved significantly and is the closest we have come to a ‘cure’ for these dysrhythmias.

Recurrence of atrial fibrillation in those who have undergone radiofrequency ablation as treatment for either atrial flutter (AFl) or AF is up to 40% at one year. There is significant evidence from animal studies that atrial fibrillation may have an inflammatory cause and blockade of angiotension II may be beneficial in its prevention. Recent evidence from clinical trials demonstrate that blockade of angiotensin II in humans leads to reduction of AF.

There is no clinical trial evidence to date of the use of angiotensin II blockade in patients post radiofrequency ablation for AF or AFl to prevent recurrent AF.

Objective: We propose to determine if angiotensin receptor blockers (ARBs) prevent recurrence of atrial fibrillation (AF) in patients who have undergone ablation for AF or AFl at one year.

Hypothesis: ARBs reduce symptomatic recurrence of atrial fibrillation post radiofrequency ablation for paroxysmal atrial fibrillation and atrial flutter.

Research Plan:

Study Design. This will be a randomized, double blind, placebo controlled trial in patients who are post catheter ablation for atrial fibrillation or atrial flutter. Randomization to either an angiotensin-receptor blocker or placebo will occur within 24 hours after the ablation procedure.

Study Population. Patients will be included if they have undergone a catheter ablation procedure for atrial fibrillation or atrial flutter. Those who have undergone a procedure for atrial flutter must also have a history of prior atrial fibrillation, hypertension, left ventricular ejection fraction </= 40% or age >/= 50 years.

Followup. Patients will be followed at 3 monthly intervals for a minimum duration of one year.

Outcome Measures. The primary outcome will be time to symptomatic recurrence of atrial fibrillation. The secondary outcome will be overall burden of atrial fibrillation at one year. The third outcome measure will be quality of life pre and post ablation. Other outcome measures include: recurrent ablation therapy, recurrent atrial tachycardia or atrial flutter, thromboembolic events, changes in biomarkers (CRP, IL-6, ANP, BNP and apelin) from baseline, to 3 months and 6 months.

Statistical Analysis. Kaplan-Meier analysis of the primary outcome will be performed. A Cox proportional hazards model will be constructed to assess the effect of variables chosen a priori on the primary outcome.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Initial catheter ablation for atrial fibrillation that is successful, defined by demonstration of four pulmonary vein isolation with lack of pulmonary vein electrical activity on a circular mapping catheter
  • Initial catheter ablation for typical atrial flutter this is successful, defined by demonstration of bidirectional block at the cavotricuspid isthmus

Exclusion Criteria:

  • Already on ACEi or ARB therapy, known intolerance to ACEi or ARBs or a known indication for ACEi/ARB therapy eg. Left ventricular dysfunction, heart failure, renal dysfunction, coronary artery disease with concomitant risk factors (increased age, diabetes)
  • Creatinine > 160 umol/L
  • Unable to give informed consent
  • Women of child-bearing potential
  • Other noncardiovascular medical condition making 1 year survival unlikely
  • Less than 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438113

Contacts
Contact: Ratika Parkash, MD MSc 902 473 4474 parkashr@cdha.nshealth.ca

Locations
Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Queen Elizabeth II Health Sciences Centre
Investigators
Principal Investigator: Ratika Parkash, MD MSc Dalhousie University/QEII HSC
  More Information

No publications provided

Study ID Numbers: RP-001
Study First Received: February 7, 2007
Last Updated: February 20, 2007
ClinicalTrials.gov Identifier: NCT00438113     History of Changes
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen Elizabeth II Health Sciences Centre:
angiotensin receptor blocker
atrial fibrillation
catheter ablation

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Valsartan
Recurrence
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on July 02, 2009