Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)
Status:
Active, not recruiting
Trial end date:
2021-08-31
Target enrollment:
Participant gender:
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
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