Actively Recruiting
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Led by Electrophysiology Research Foundation · Updated on 2024-05-23
360
Participants Needed
9
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with symptomatic heart failure with preserved systolic function and paroxysmal or persistent atrial fibrillation
- Willing and able to give written informed consent
- Outpatients aged 50 years or older, male or post-menopausal female; premenopausal females must use continuous birth control during the study
- Documented HFpEF and paroxysmal or persistent AF with either symptomatic heart failure requiring diuretics for at least 30 days before entry, hospitalization for HF or AF in past 12 months with elevated NT-pro BNP levels, or evidence of structural heart disease by echocardiography
- Left ventricular ejection fraction greater than 45% within 6 months prior to enrollment
- Candidates for clinically indicated catheter ablation and antiarrhythmic drug therapy
- On one or more standard heart failure drug therapies for at least 30 days
- Candidates for long-term oral anticoagulant therapy based on clinical guidelines
You will not qualify if you...
- Not on any drug therapy for heart failure or having uncontrolled hypertension (systolic BP >180 mm Hg or >150 mm Hg on three or more antihypertensive drugs)
- QRS duration greater than 120 ms or intraventricular conduction defects with current or potential ventricular resynchronization therapy
- Recent myocardial infarction or acute coronary syndrome within 1 month
- Recent coronary revascularization within 3 months
- Documented left atrial thrombus or left ventricular ejection fraction less than 40%
- Not candidates for rate or rhythm control drug therapy for AF
- Dilated cardiomyopathy due to reversible causes like myocarditis
- Contraindications or adverse reactions to anticoagulants like Warfarin or DOACs
- Creatinine clearance less than 30 ml/min or greater than 95 ml/min
- Advanced liver or lung disease, significant congenital heart disease, pericardial constriction, hypertrophic or infiltrative cardiomyopathy, or severe valvular heart disease
- Recent stroke, transient ischemic attack, thromboembolic event, or carotid angioplasty within 3 months
- Recent major bleeding or intracranial bleeding within 3 months
- Candidates for organ transplantation or left ventricular assist devices, recent cardiac surgery within 3 months
- Needing ACE inhibitor or ARB therapy for any reason
- History of hypersensitivity to antiarrhythmic drugs
- Other significant medical conditions precluding participation
- Life expectancy less than 1 year
- Premenopausal females not on continuous birth control or likely to discontinue it
- Pregnant, nursing, or women of childbearing potential not on effective contraception
- Noncompliance with medical regimens or social issues limiting follow-up, history of alcohol or drug abuse in past 12 months
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Northern Arizona Health Care
Flagstaff, Arizona, United States, 86001
Actively Recruiting
2
St. Bernards Heart and Vascular Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
3
South Denver Cardiology
Littleton, Colorado, United States, 80120
Actively Recruiting
4
Kansas City Heart Rhythm Institute
Overland, Missouri, United States, 66211
Actively Recruiting
5
Electrophysiology Research Foundation
Warren Township, New Jersey, United States, 07059
Actively Recruiting
6
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
TCAI at St. David's Hospital
Austin, Texas, United States, 78705
Actively Recruiting
8
Peter Osypka Herzzentrum
Munich, Bavaria, Germany, 81379
Not Yet Recruiting
9
Hopitaux Universitaires de Geneve
Geneva, Canton of Geneva, Switzerland, 1205
Actively Recruiting
Research Team
S
SANJEEV SAKSENA, MD
CONTACT
C
Carine Carvalhiero, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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