Premature Ventricular Contractions (PVCs) and Blood Pressure Control

Phase 2

Terminated

• Conditions: Ventricular Premature Complexes; Blood Pressure
• Interventions: Drug: PVC Suppression using Flecainide; Drug: No PVC Suppression using Placebo

• Registration Number: NCT01833455
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2018-08-21
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Results First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PVC Suppression then Placebo	No PVC Suppression using Placebo	This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
Placebo then PVC Suppression	No PVC Suppression using Placebo	This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
Placebo then PVC Suppression	PVC Suppression using Flecainide	This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
PVC Suppression then Placebo	PVC Suppression using Flecainide	This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Pressure	Baseline and 28 days	Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.

Secondary Outcome Measures

Name	Time	Method
Change in Muscle Sympathetic Nerve Activity	Baseline and 28 days	Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States