Premature Ventricular Contractions (PVCs) and Blood Pressure Control

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

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.

Study Overview

• Status: Terminated
• Conditions: Blood Pressure; Ventricular Premature Complexes
• Intervention / Treatment: Drug: PVC Suppression using Flecainide; Drug: No PVC Suppression using Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PVC Suppression then Placebo; 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; Flecainide will be administered to result in a reduction in PVC burden.; Other Names: Tambocor; Drug: No PVC Suppression using Placebo; Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Placebo Comparator: Placebo then PVC Suppression; 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; Flecainide will be administered to result in a reduction in PVC burden.; Other Names: Tambocor; Drug: No PVC Suppression using Placebo; Placebo (sugar pills) will be given to result in no alteration in PVC burden.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baroreflex Gain	Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.	Baseline and 28 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Mohamed H Hamdan, MD, MBA, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Premature Birth; Ventricular Premature Complexes; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Flecainide
• Other Study ID Numbers: UW-PVC-2012-0510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No