Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on February 07, 2013 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Aggressive Blood Pressure control (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Capital District Health Authority, Canada Official(s) and/or principal investigator(s): Ratika Parkash, MD MSc, Principal Investigator, Affiliation: Dalhousie University/QEII HSC
Overall contact: Ratika Parkash, MD MSc, Phone: 902 473 4474, Email: parkashr@cdha.nshealth.ca
Summary
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.
Clinical Details
Official title: Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Time to recurrent Atrial fibrillation
Secondary outcome: Recurrence of AF at one year
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
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ratika Parkash, MD MSc, Phone: 902 473 4474, Email: parkashr@cdha.nshealth.ca
QE II Health Sciences Centre, Halifax, Nova Scotia B3H 3A7, Canada; Recruiting Ratika Parkash, MD MSc, Principal Investigator
Additional Information
Starting date: December 2009
Last updated: November 8, 2012
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