Premature Ventricular Contractions (PVCs) and Blood Pressure Control

• ClinicalTrials.gov Identifier: NCT01833455
• Recruitment Status: Terminated
• First Posted: April 16, 2013
• Results First Posted: February 22, 2019
• Last Update Posted: February 22, 2019
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

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.

Condition or disease	Intervention/treatment	Phase
Ventricular Premature Complexes; Blood Pressure	Drug: PVC Suppression using Flecainide; Drug: No PVC Suppression using Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
• Study Start Date: February 2013
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Drug: PVC Suppression using Flecainide; Flecainide will be administered to result in a reduction in PVC burden.; Other Name: Tambocor; Drug: No PVC Suppression using Placebo; Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Placebo Comparator: 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.	Drug: PVC Suppression using Flecainide; Flecainide will be administered to result in a reduction in PVC burden.; Other Name: Tambocor; Drug: No PVC Suppression using Placebo; Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Outcome Measures

Primary Outcome Measures :

1. Change in Mean Arterial Pressure [ Time Frame: Baseline and 28 days ]
   Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.

Secondary Outcome Measures :

1. Change in Muscle Sympathetic Nerve Activity [ Time Frame: Baseline and 28 days ]
   Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.

Other Outcome Measures:

1. Change in Baroreflex Gain [ Time Frame: Baseline and 28 days ]
   Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Mohamed H Hamdan, MD, MBA; University of Wisconsin, Madison

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01833455
• Other Study ID Numbers: UW-PVC-2012-0510
• First Posted: April 16, 2013
• Results First Posted: February 22, 2019
• Last Update Posted: February 22, 2019
• Last Verified: January 2019

• 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

Additional relevant MeSH terms:

Premature Birth; Ventricular Premature Complexes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Flecainide; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action