Premature Ventricular Contractions (PVCs) and Blood Pressure Control

NCT01833455 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: UW-PVC-2012-0510
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Premature Complexes; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in Mean Arterial Pressure

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

  Baseline and 28 days

Secondary Outcomes (1)

• Change in Muscle Sympathetic Nerve Activity

  Baseline and 28 days

Other Outcomes (1)

• Change in Baroreflex Gain

  Baseline and 28 days

Study Arms (2)

PVC Suppression then Placebo

PLACEBO COMPARATOR

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

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

Placebo then PVC Suppression

PLACEBO COMPARATOR

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

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

Interventions

PVC Suppression using Flecainide DRUG

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

Also known as: Tambocor

PVC Suppression then Placebo; Placebo then PVC Suppression

No PVC Suppression using Placebo DRUG

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

PVC Suppression then Placebo; Placebo then PVC Suppression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Frequent symptomatic premature ventricular contractions (PVCs) (\>10% of total QRSs on a 24-hour Holter)
• Willingness to participate in research

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Flecainide

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was terminated prematurely due to a loss of staff available to make the technical measurements involved. The small number of data points available lead us to conclude the data is uninterpretable.

Results Point of Contact

• Title: Stephen Wasmund, PhD
• Organization: University of Wisconsin

stephen.wasmund@carma.utah.edu

801-587-3740

Study Officials

• Mohamed H Hamdan, MD, MBA

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 16, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 22, 2019
• Results First Posted: February 22, 2019

Record last verified: 2019-01

Locations

US (1)