Premature Ventricular Contractions (PVCs) and Blood Pressure Control

NCT ID: NCT01833455

Last Updated: 2019-02-22

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-06-30

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.

Detailed Description

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Conditions

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Ventricular Premature Complexes Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

PVC Suppression using Flecainide

Intervention Type DRUG

Flecainide will be administered to result in a reduction in PVC burden.

No PVC Suppression using Placebo

Intervention Type DRUG

Placebo (sugar pills) will be given to result in no alteration in PVC burden.

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.

Group Type PLACEBO_COMPARATOR

PVC Suppression using Flecainide

Intervention Type DRUG

Flecainide will be administered to result in a reduction in PVC burden.

No PVC Suppression using Placebo

Intervention Type DRUG

Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Interventions

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PVC Suppression using Flecainide

Flecainide will be administered to result in a reduction in PVC burden.

Intervention Type DRUG

No PVC Suppression using Placebo

Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Intervention Type DRUG

Other Intervention Names

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Tambocor

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed H Hamdan, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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UW-PVC-2012-0510

Identifier Type: -

Identifier Source: org_study_id

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