Suspended

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

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What is being tested

PVC Suppression using Flecainide

+ No PVC Suppression using Placebo

+ PVC Suppression using Flecainide

Drug
Who is being recruted

Cardiac Conduction System Disease+5

+ Arrhythmias, Cardiac

+ Cardiovascular Diseases

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 2
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Wisconsin, Madison
Last updated: February 22, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01833455
Principal SponsorUniversity of Wisconsin, Madison
Last updated: February 22, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiac Conduction System DiseaseArrhythmias, CardiacCardiovascular DiseasesCardiac Complexes, PrematureHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVentricular Premature Complexes

Criteria

2 inclusion criteria required to participate
Frequent symptomatic premature ventricular contractions (PVCs) ( > 10% of total QRSs on a 24-hour Holter)
Willingness to participate in research
14 exclusion criteria prevent from participating
Age > 65 years old
Atrio-ventricular (AV) block
Creatinine clearance of 35 mL/min/1.73 square meters or less
History of myocardial infarction or coronary artery disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

100% chance of being blinded to the placebo group

Treatment Groups

Group I

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 II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Wisconsin

Madison, United StatesOpen University of Wisconsin in Google Maps
SuspendedOne Study Center