Premature Ventricular Contractions (PVCs) and Blood Pressure Control

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Ventricular Premature Complexes; Blood Pressure

Treatments: Drug: No PVC Suppression using Placebo; Drug: PVC Suppression using Flecainide

Study type: Interventional

Funder types: Other

Identifiers

NCT01833455

UW-PVC-2012-0510

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

PVC Suppression then Placebo

Placebo Comparator group

Description:

This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.

Treatment:

Drug: PVC Suppression using Flecainide

Drug: No PVC Suppression using Placebo

Placebo then PVC Suppression

Placebo Comparator group

Description:

This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.

Treatment:

Drug: PVC Suppression using Flecainide

Drug: No PVC Suppression using Placebo