Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF (SMAC AF)
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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 aggressive BP lowering will reduce the rate of recurrent AF after catheter ablation for AF. We plan a randomized clinical trial of aggressive BP lowering versus standard BP control to investigate this. The primary outcome will be time to recurrent AF.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Other: Aggressive Blood Pressure control |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF |
- Time to recurrent Atrial fibrillation [ Time Frame: one year ] [ Designated as safety issue: No ]
- Recurrence of AF at one year [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 184 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Aggressive Blood Pressure control
|
Other: Aggressive Blood Pressure control
Aggressive Blood Pressure therapy, alone or combination therapy, to reach a target BP equal to or less than 120/80 mmHg
Other Names:
|
|
Active Comparator: 2
Standard Blood Pressure control
|
Other: Aggressive Blood Pressure control
Aggressive Blood Pressure therapy, alone or combination therapy, to reach a target BP equal to or less than 120/80 mmHg
Other Names:
|
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 AF is up to 40% at one year and higher in those with persistent AF. Hypertension is a potent risk factor for AF, but recent studies have demonstrated that even modest increases in BP may lead to a higher incidence of AF. There is no clinical trial evidence to date that has investigated aggressive BP control in patients post radiofrequency ablation for AF to prevent recurrent AF.
Objective: We propose to determine if aggressive BP control reduces recurrent AF post ablation.
Hypothesis: Aggressive BP lowering will reduce the incidence of recurrent AF post ablation.
Research Plan:
Study Design. This will be a randomized open label trial in patients who are post catheter ablation for atrial fibrillation. Randomization to either aggressive BP lowering or standard BP control will occur six months prior to the procedure.
Study Population. Patients will be included if they have persistent AF and intend to have a catheter ablation procedure for AF.
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 and BNP) 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 |
Inclusion Criteria:
Persistent AF to undergo catheter ablation
Exclusion Criteria:
- 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| Contact: Ratika Parkash, MD MSc | 902 473 4474 | parkashr@cdha.nshealth.ca |
| Canada, Nova Scotia | |
| QE II Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Principal Investigator: Ratika Parkash, MD MSc | |
| Principal Investigator: | Ratika Parkash, MD MSc | Dalhousie University/QEII HSC |
More Information
No publications provided
| Responsible Party: | Ratika Parkash, Staff Cardiologist, Electrophysiology, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00438113 History of Changes |
| Other Study ID Numbers: | RP-001 |
| Study First Received: | February 7, 2007 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Capital District Health Authority, Canada:
|
blood pressure atrial fibrillation catheter ablation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013