Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
A Phase 4, Randomized, Open Label, Multicenter Prospective Comparative Study To Evaluate The Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Electrophysiology Research Foundation
360 participants
Jul 26, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Subjects must be willing and able to give written informed consent
- Outpatients ≥ 50 years of age, male or post- menopausal female patients; premenopausal female patients who are on and will maintain continuous birth control therapy during the study.
- Patients should be on one or more standard heart failure drug therapy (ies) for heart failure with preserved cardiac function for at least 30 days
- Written informed consent for the clinically indicated study procedures
- Patients must be candidates for long-term OAC therapy based on clinical practice guidelines for treatment of AF. Guidelines for GFR as established for DOACSs will be applicable to all subjects.
Exclusion Criteria20
- 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.
Interventions
Delivery of physical energy from external energy source via percutaneously inserted electrophysiologic catheter to destroy heart tissue in the human atrium and adjoining vasculature
Administration of antiarrhythmic drug to achieve either rate control or restoration of sinus rhythm for management of atrial fibrillation
Insertion of wireless hemodynamic monitor to provide hemodynamic data to guide heart failure therapy to achieve heart failure improvement.
Administration of heart failure drug therapy based on clinical evaluation to achieve heart failure improvement.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04160000