Ablation Versus Medical Management of Atrial Fibrillation in HFpEF (AMPERE)
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|ClinicalTrials.gov Identifier: NCT04282850|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Heart Failure With Normal Ejection Fraction||Procedure: Pulmonary Vein Isolation||Not Applicable|
Recent studies using PVI for rhythm control in patients with heart failure with reduced ejection fraction (HFrEF) have shown improvement in systolic ejection fraction, exercise capacity, quality of life, and a significant reduction in all-cause mortality. The PVI procedure has been shown to be safe and comparably effective in treating Atrial Fibrillation (AF) in HFpEF patients, but no studies have yet demonstrated the effects of catheter ablation on exercise capacity or clinical outcomes.
The investigators propose a prospective, non-blinded randomized control pilot study to assess the feasibility of conducting larger scale studies to determine if there are differences between catheter ablation with medical management on exercise capacity and quality of life in HFpEF patients with AF. The investigators' study will be powered for AF burden reduction, and the investigators hope to use the effect size on exercise capacity and heart failure events to help determine power for larger clinical studies that will follow to shed light on how invasive management of atrial fibrillation may impact the natural history of individuals with these two cardiovascular conditions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2:1 randomization to catheter ablation (PVI) or to medical management.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Serum biomarkers, atrial fibrillation burden, anatomical and functional echocardiographic parameters, and exercise capacity will all be measured and analyzed by study personnel blinded to the patient's intervention.|
|Official Title:||Ablation Versus Medical Management of Atrial Fibrillation in Heart Failure With Preserved Ejection fRaction and the Effects on Exercise Capacity (AMPERE)|
|Actual Study Start Date :||February 29, 2020|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
Experimental: Pulmonary Vein Isolation (PVI) Group
Subjects randomized to this treatment arm will undergo atrial fibrillation ablation, and undergo routine post-procedural follow-up.
Procedure: Pulmonary Vein Isolation
The intervention will involve standard of care electrophysiology ablation for rhythm management of atrial fibrillation with a procedure called a pulmonary vein isolation.
Other Name: Atrial fibrillation ablation
No Intervention: Medical Management
Subjects randomized to this treatment arm will undergo medical management of the arrhythmia, but will not undergo invasive electrophysiologic procedures to address subject's AF.
- Change in AF burden as assessed by difference in percentage of time an individual is in AF [ Time Frame: 3, 6, 9, and 12 months from intervention ]AF burden, described as the percentage of time an individual is in AF relative to the total amount of time analyzed. This outcome will be assessed at multiple intervals following intervention arm, using a continuous, implantable heart rhythm monitor. The investigators' focus will be on the change between pre-intervention AF burden and AF burden at 6 month follow-up.
- All-cause mortality [ Time Frame: 12 months ]All deaths within 12 months of the intervention arm.
- Number of cardiovascular mortalities [ Time Frame: 12 months ]The number of deaths attributable to cardiovascular causes occurring within 12 months of the intervention arm
- Number of all-cause hospitalizations [ Time Frame: 12 months ]The total number of inpatient hospitalizations within 12 months following the intervention.
- Number of heart failure hospitalizations [ Time Frame: 12 months ]The total number of inpatient hospitalizations attributable to heart failure exacerbations within 12 months following the intervention.
- Change in patient-reported quality of life as assessed by Kansas City Cardiomyopathy Questionnaire [ Time Frame: At enrollment (baseline) and 6 months following intervention ]The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. A change of 10 points or more is considered not only clinically significant but also carries prognostic implications for event-free survival in heart failure patients.
- Change in NT pro-BNP levels [ Time Frame: At enrollment (baseline) and 6 months following intervention ]Serum biomarker associated with congestive heart failure symptoms, measured in (mg/ml).
- Change in exercise capacity as assessed by the 6 minute walk distance test [ Time Frame: At baseline and 6 months post intervention ]Pre-intervention arm and 6 month post-procedural exercise capacity will be assessed using change in 6 minute walk distance, defined as the total distance (in meters) traversed during 6 minutes of time. This is well-validated measure of functional capacity and prognostic marker in patients with heart failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282850
|Contact: Eunice Yang, MDfirstname.lastname@example.org|
|Contact: Carol Tunin, PhD||410 email@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Eunice Yang, MD 410-614-8449 firstname.lastname@example.org|
|Contact: David Spragg, MD email@example.com|
|Principal Investigator: David Spragg, MD|
|Sub-Investigator: Eunice Yang, MD|
|Sub-Investigator: Hugh Calkins, MD|
|Sub-Investigator: Kavita Sharma, MD|
|Study Chair:||Hugh Calkins, MD||Johns Hopkins University|
|Principal Investigator:||David Spragg, MD||Johns Hopkins University|
|Study Director:||Kavita Sharma, MD||Johns Hopkins University|