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Atrial Fibrillation | Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF

Atrial Fibrillation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Documented systolic blood pressure greater than or equal to 130 mmHg - Undergoing planned catheter ablation for persistent AF (lasting > 7 days and < 365 days or requiring electrical or chemical cardioversion) OR High burden paroxysmal AF > 6 months (greater than or equal to 3 symptomatic episdes in past 6 months and refractory or inteolerant to at least 1 class 1 or 3 antiarrhythmic) Exclusion Criteria: - Permanent atrial fibrillation - Contraindication to Accupril or any other ACE-I - Women of child-bearing potential - Life expectancy less than 1 year - Less than 18 years of age - Unable to give informed consent - Known moderate to several renal dysfunction (eGFR < 30 ml/min/1.73m2) - Prior AF catheter ablation

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Atrial Fibrillation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Aggressive Blood Pressure controlAggressive Blood Pressure therapy, alone or combination therapy, to reach a target BP equal to or less than 120/80 mmHg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Aggressive Blood Pressure controlThe experimental arm will receive open label therapy to achieve a target systolic blood pressure less than or equal to 120 mmHg. If the average BP is found to be > 120 mmHg at the baseline, telephone or clinic followup visits, treatment will be recommended based on the following regimen (For details, please see Appendix 4): Step 1 - Accupril, titrated to maximum tolerated dose, beginning at 20 mg po od followed by 40 mg successively Step 2 - combination of Accupril with Hydrochlorothiazide 12.5 mg po od. Step 3 - Addition of Atenolol 50 mg po od. Step 4 - Addition of Norvasc 2.5-10 mg po od. Step 5 - Addition of Terazosin 1 mg po od.

Standard Blood Pressure controlTreatment will be carried out as per the CHEP guidelines. These patients may require ACEi or ARBs for their treatment. No changes to their drug regimen will be made as long as BP measurements are congruent with current guidelines. These modifications will be made as per standard practice by the physician who is primarily involved with their care (this may be a family physician or a specialist, depending on the patient). Patients with diabetes in the standard arm will be treated to a target BP of <130/80 as per the CHEP guidelines.

Study Status

Completed

Start Date: December 2009

Completed Date: September 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Time to symptomatic AF/atrial tachycardia (AT)/atrial flutter (AFl) lasting > 30 seconds more than 3 months post ablation.

Secondary Outcome: Any recurrent atrial fibrillation/atrial tachycardia/atrial flutter post randomization

Study sponsors, principal investigator, and references

Principal Investigator: Ratika Parkash, MD MSc

Lead Sponsor: Nova Scotia Health Authority

Collaborator: Nova Scotia Health Research Foundation

More information:https://clinicaltrials.gov/show/NCT00438113

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