Premature Ventricular Contractions (PVCs) and Blood Pressure Control

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01833455
• Other study ID #: UW-PVC-2012-0510
• Status: Terminated
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Premature Birth
• Ventricular Premature Complexes

Intervention

Drug:
• PVC Suppression using Flecainide
Flecainide will be administered to result in a reduction in PVC burden.
• No PVC Suppression using Placebo
Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Baroreflex Gain	Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.	Baseline and 28 days
Primary	Change in Mean Arterial Pressure	Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.	Baseline and 28 days
Secondary	Change in Muscle Sympathetic Nerve Activity	Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.	Baseline and 28 days