Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)

Summary

Premature ventricular contractions (PVCs) coexist in patients with heart failure (HF) and LV dysfunction. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM).

This clinical pilot study will enroll 36 patients with frequent PVCs (burden \>10%) and CM (LVEF \<45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, patients will undergo a baseline cardiac MR if clinically indicated followed by 3-month observation period (optimal HF medical therapy). Changes in LV function/scar, PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events will be assessed throughout the observation period and compare with PVC suppression strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis. In addition, a total of 20,000 consecutive ambulatory ECG Holter monitors from all participating centers will be screened to identify all patients with probable diagnosis of PVC-CM.

This pilot study is intended to estimate the prevalence of this clinical entity and pave the way for a large full scale randomized trial to identify best treatment strategy for patients with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient's health and subsequently decrease HF healthcare spending.

Conditions

• Ventricular Premature Beats, Contractions, or Systoles
• Cardiomyopathies

Interventions

PROCEDURE

Radiofrequency ablation

RFA to achieve PVC suppression will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study.

DRUG

Amiodarone (Antiarrhythmic drug)

AAD therapy of choice is amiodarone. Amiodarone loading dose of 10 grams is recommended, followed by maintenance dose of 200-400mg daily to achieve successful PVC suppression. Alternatively, sotalol and/or propafenone could be considered at discretion of electrophysiologists (sotalol dose of at least 120mg twice daily, propafenone 150-300mg tid) if there is a significant concern of safety profile of amiodarone.

Sponsors & Collaborators

• Virginia Commonwealth University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Hunter Holmes Mcguire Veteran Affairs Medical Center

  lead FED

Principal Investigators

• Jose F Huizar, M.D. · McGuire VA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2021-08-31

Completion

2021-08-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations