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Premature Ventricular Contractions (PVCs) and Blood Pressure Control

Primary Purpose

Ventricular Premature Complexes, Blood Pressure

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PVC Suppression using Flecainide
No PVC Suppression using Placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ventricular Premature Complexes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

PVC Suppression then Placebo

Placebo then PVC Suppression

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Mean Arterial Pressure
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.

Secondary Outcome Measures

Change in Muscle Sympathetic Nerve Activity
Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.

Full Information

First Posted
April 9, 2013
Last Updated
January 29, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01833455
Brief Title
Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Official Title
The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment.
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Premature Complexes, Blood Pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVC Suppression then Placebo
Arm Type
Placebo Comparator
Arm Description
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
Arm Title
Placebo then PVC Suppression
Arm Type
Placebo Comparator
Arm Description
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
Intervention Type
Drug
Intervention Name(s)
PVC Suppression using Flecainide
Other Intervention Name(s)
Tambocor
Intervention Description
Flecainide will be administered to result in a reduction in PVC burden.
Intervention Type
Drug
Intervention Name(s)
No PVC Suppression using Placebo
Intervention Description
Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Primary Outcome Measure Information:
Title
Change in Mean Arterial Pressure
Description
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
Change in Muscle Sympathetic Nerve Activity
Description
Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.
Time Frame
Baseline and 28 days
Other Pre-specified Outcome Measures:
Title
Change in Baroreflex Gain
Description
Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.
Time Frame
Baseline and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed H Hamdan, MD, MBA
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Premature Ventricular Contractions (PVCs) and Blood Pressure Control

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