Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

Status unconfirmed · Phase 4

Conditions studied: Atrial Fibrillation, Heart Failure, Diastolic Heart Failure

In brief

Heart failure (HF) with preserved left ventricular function (pEF) is difficult clinical syndrome to treat effectively with few evidence based therapies. Atrial fibrillation (AF) is now an important co-morbidity being observed in 43% of patients with HFpEF. Rhythm control has not been studied in this population. Catheter ablation and antiarrhythmic drugs are rhythm control therapies that have been used for treatment of AF without HF or HF with reduced systolic function but have not been widely applied in HFpEF. No controlled comparative evaluation has been performed in HFpEF. The introduction of wireless pulmonary artery hemodynamic monitoring has permitted optimization of HF therapy in patients with chronic HF with reduced and preserved EF. Reduction in HF hospitalizations has been observed in post hoc analyses of HFpEF patients but has not been systematically applied in AF patients with HFpEF. In this study, we propose to study both rhythm control and optimized HF therapeutic approaches in an AF with HFpEF study population in a pilot study using a sequential two phase randomized controlled clinical trial design.

Key facts

Study ID

NCT04160000

Run by

Electrophysiology Research Foundation

People needed

360

Starts

2020-07-26

Expected to finish

2025-06-30

Last updated by the study team

2024-05-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with HFpEF who were not on any drug therapy for HF or have uncontrolled hypertension defined as systolic BP >180 mm Hg at screening or >150 mm Hg on three or more antihypertensive drugs
• Patients with QRS duration of >120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy
• Recent (<1 month) myocardial infarction or acute coronary syndrome
• Recent (<3 months) coronary revascularization procedures
• Documented LA thrombus on TEE or any LVEF measurement <40%
• Patients who are not candidates for Rate or Rhythm control drug therapy for AF
• Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis
• Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy
• Creatinine clearance <30ml/min or >95ml/min
• Advanced hepatic disease, pulmonary disease clinically significant congenital heart disease, clinically significant pericardial constriction, hypertrophic cardiomyopathy, infiltrative cardiomyopathy, decompensated valvular heart disease likely to require surgical or percutaneous intervention during the trial
• Recent stroke (<3 months) or thromboembolic event, transient ischemic attack or carotid angioplasty in the prior 3 months
• Recent (<3 months) intracranial or other major bleeding event
• Candidates for heart or any other organ transplantation or left ventricular assist devices, recent (< 3 months) valve or other cardiac surgery
• Patients requiring ACE inhibitor or ARB drug therapy for any reason
• History of hypersensitivity to antiarrhythmic drugs
• Patients with other clinically significant medical condition that precludes study participation
• Patients with life expectancy < 1 year
• Premenopausal female patients, who are not on continuous birth control therapy or are likely to discontinue it at any time during the entire duration of study enrollment.
• Pregnant or nursing lactating mothers or women of childbearing potential who are not on effective contraceptive therapy
• Patients who have been noncompliant with medical regimens or have social or other issues precluding regular follow up, history of alcohol or drug abuse in past 12 months.

Where it is running

• Hopitaux Universitaires de Geneve — Geneva, Canton of Geneva, Switzerland (enrolling)
• St. Bernards Heart and Vascular Center — Jonesboro, Arkansas, United States (enrolling)
• South Denver Cardiology — Littleton, Colorado, United States (enrolling)
• Kansas City Heart Rhythm Institute — Overland, Missouri, United States (enrolling)
• Electrophysiology Research Foundation — Warren Township, New Jersey, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• TCAI at St. David's Hospital — Austin, Texas, United States (enrolling)
• Northern Arizona Health Care — Flagstaff, Arizona, United States (enrolling)
• Peter Osypka Herzzentrum — Munich, Bavaria, Germany

Full record on ClinicalTrials.gov

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