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Premature Ventricular Contractions (PVCs) and Blood Pressure Control

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Terminated
Phase 2

Conditions

Ventricular Premature Complexes
Blood Pressure

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01833455
UW-PVC-2012-0510

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

8 participants in 2 patient groups, including a placebo group

PVC Suppression then Placebo
Placebo Comparator group
Description:
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
Treatment:
Drug: PVC Suppression using Flecainide
Drug: No PVC Suppression using Placebo
Placebo then PVC Suppression
Placebo Comparator group
Description:
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
Treatment:
Drug: PVC Suppression using Flecainide
Drug: No PVC Suppression using Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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