Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)
PAPS
2 other identifiers
interventional
5
2 countries
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2018
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedApril 14, 2021
April 1, 2021
3.1 years
July 18, 2017
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement of left ventricular ejection fraction after PVC suppression
Compare the overall improvement or change in LVEF between RFA and AAD groups.
12 months
Responders to PVC suppression strategy
Assessment of the number of responders (delta LVEF ≥ 10%) after PVC suppression strategies will assess the effectiveness of RFA and AADs to reverse or improve cardiomyopathy induced by frequent PVCs.
12 months
Secondary Outcomes (3)
Successful PVC suppression
12 months
Composite Adverse Events
12 months
Composite Arrhythmia Burden
12 months
Study Arms (2)
Radiofrequency Ablation
ACTIVE COMPARATORRadiofrequency ablation (RFA) will be performed after 3-month observation period. EPS and RFA will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study. In the event of polymorphic PVCs, all morphologies are to be targeted for ablation
Antiarrhythmic Drug
ACTIVE COMPARATORAntiarrhythmic drugs (AADs) will be only initiated after 3-month observation period. 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. Investigators define successful PVC suppression only if ≥ 80% absolute reduction in PVC burden is achieved after a drug or intervention. 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hunter Holmes Mcguire Veteran Affairs Medical Centerlead
- Virginia Commonwealth Universitycollaborator
- University of California, San Franciscocollaborator
- University of Calgarycollaborator
- Washington University School of Medicinecollaborator
- Wake Forest University Health Sciencescollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (11)
University of California Los Angeles Medical Center
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94143, United States
James A. Haley Veterans' Hospital
Tampa, Florida, 33612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Roxbury VA Medical Center
West Roxbury, Massachusetts, 02132, United States
Northwell Health System-Staten Island University Hospital
Staten Island, New York, 10305, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Libin Cardiovascular Institute, University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Related Publications (1)
Torrado J, Sima A, Comstuck C, Kaszala K, Tan A, Koneru J, Frankel DS, Marchlinski F, Kowalski M, Sharma P, Gerstenfeld EP, Vaseghi M, Shivkumar K, Malhotra R, Morillo C, Ellenbogen KA, Huizar JF. Prevalence of frequent premature ventricular contractions and left-ventricular systolic dysfunction in patients receiving Holter monitoring. J Cardiovasc Electrophysiol. 2025 Jan;36(1):54-61. doi: 10.1111/jce.16478. Epub 2024 Oct 24.
PMID: 39445764DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jose F Huizar, M.D.
McGuire VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Arrhythmia and Device Clinic
Study Record Dates
First Submitted
July 18, 2017
First Posted
July 25, 2017
Study Start
August 1, 2018
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
April 14, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 3-6 months after pilot study has been completed
This is solely a pilot study of frequent PVCs and cardiomyopathy. Results of this preliminary data will not provide final definitive data, yet investigators will make it available. However, investigators will make clear that this pilot data is not intended to answer benefits of different PVC suppression strategies to avoid misinterpretation or inaccurate conclusions based solely on preliminary data.