Premature Ventricular Contractions (PVCs) and Blood Pressure Control

Study Overview
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Brief Summary
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The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.

Official Title
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The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs

Conditions
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Ventricular Premature Complexes, Blood Pressure

Intervention / Treatment
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* Drug: PVC Suppression using Flecainide
* Drug: No PVC Suppression using Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on a 24-hour Holter) Willingness to participate in research Exclusion Criteria: Age > 65 years old Pacemaker implantation Implantable cardioverter defibrillator implantation requiring pacing Sick sinus syndrome Atrio-ventricular (AV) block Left ventricular dysfunction defined as left ventricular ejection fraction < 50% History of myocardial infarction or coronary artery disease Severe left ventricular hypertrophy (wall thickness > 1.5 cm by echocardiography performed within 3 months from enrollment) Severe liver dysfunction Creatinine clearance of 35 mL/min/1.73 square meters or less Pregnancy Known hypersensitivity to the drug QRS duration > 120 ms Recent change in blood pressure medication within 30 days of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PVC Suppression then Placebo<br>This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. | Drug: PVC Suppression using Flecainide<br>* Flecainide will be administered to result in a reduction in PVC burden.<br>* Other names: Tambocor;Drug: No PVC Suppression using Placebo<br>* Placebo (sugar pills) will be given to result in no alteration in PVC burden.<br>|
| Placebo Comparator: Placebo then PVC Suppression<br>This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. | Drug: PVC Suppression using Flecainide<br>* Flecainide will be administered to result in a reduction in PVC burden.<br>* Other names: Tambocor;Drug: No PVC Suppression using Placebo<br>* Placebo (sugar pills) will be given to result in no alteration in PVC burden.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Arterial Pressure | Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements. | Baseline and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle Sympathetic Nerve Activity | Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats. | Baseline and 28 days |