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

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Univeristy of Calgary; University of Calgary; University of California, San Francisco; University of Pittsburgh; Virginia Commonwealth University; Wake Forest University Health Sciences; Washington University School of Medicine
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Propafenone

Criteria

Inclusion Criteria:

• LV dysfunction (calculated LVEF < or equal to45% based on Echo) within 150 days of Enrollment (Day 0)

• PVC burden > or equal to 10% by at least a 24-hr ambulatory Holter monitor (within 150 days of Enrollment (Day 0)

Exclusion Criteria:

• Age < 18 years old

• Current amiodarone use or within last 2 months

• Current use of antiarrhythmic drugs class I or III

• Contraindication to amiodarone use or any other class III antiarrhythmic

• Severely symptomatic PVCs (unable to complete 3-month observation period)

• Severe/significant CAD with planned revascularization in the near future

• Complete AV block and pacemaker dependent

• Pacemaker or ICD with >10% RV pacing

• Severe valvular heart disease or planned valvular/cardiac surgery

• Uncontrolled / untreated endocrinopathies

• Uncontrolled HTN, (systolic BP >180mmHg or diastolic >110 mmHg)

• Hypertrophic cardiomyopathy

• Systemic infiltrative and immune disorders

• Family history of dilated CM in a first degree relative

• Alcohol abuse or illicit drug use

• Contraindication to short-term acute anticoagulation (due to possible randomization to ablation)

• Atrial fibrillation and flutter with rapid ventricular response with possible tachycardia-induced cardiomyopathy

• Possible infectious etiology of cardiomyopathy

• Pregnant or lactating women

• Previous PVC ablation