RECRUITING

Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

Conditions

Atrial Fibrillation Heart Failure Diastolic Heart Failure Catheter Ablation Antiarrhythmic Drugs

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 4, Randomized, Open Label, Multicenter Prospective Comparative Study To Evaluate The Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

Quick Facts

Study Start:2020-07-26

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04160000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects must be willing and able to give written informed consent 2. 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. 3. Subjects must have documented HFpEF \& paroxysmal or persistent AF and satisfy one of the following inclusion criteria a) Consecutive patients with AF, symptomatic heart failure requiring diuretic therapy for at least 30 days prior to study entry b) Hospitalization for HF and/or AF in the past 12 months prior to catheter ablation with documented NT-pro BNP \>200pg/ml for patients not in AF or \> 600 pg/ml for patients in AF on screening ECG or NYHA class 2, 3 or ambulatory class 4 heart failure documented NT-pro BNP \>300pg/ml for patients not in AF or \> 900 pg/ml for patients in AF on screening ECG c).Evidence of structural heart disease defined as by at least 1 of the following echocardiography findings (any local measurement made during the screening epoch or within the 6 months prior to screening visit): 1) LA enlargement defined by at least 1 of the following: LA width (diameter) \>3.8 cm or LA length \>5.0 cm or LA area \>20 cm2 or LA volume \>55 ml or LA volume index \>29 ml/m2 2) LVH defined by septal thickness or posterior wall thickness \>1.1 cm d).Left ventricular ejection fraction \> 45% using standard imaging techniques at enrollment for study or in prior 6 months e).ECG documented paroxysmal or persistent atrial fibrillation f).Patients are candidates for a clinically indicated catheter ablation procedure, and Rate or Rhythm control antiarrhythmic drug therapy 4. 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 5. Written informed consent for the clinically indicated study procedures 6. 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.	1. 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 2. Patients with QRS duration of \>120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy 3. Recent (\<1 month) myocardial infarction or acute coronary syndrome 4. Recent (\<3 months) coronary revascularization procedures 5. Documented LA thrombus on TEE or any LVEF measurement \<40% 6. Patients who are not candidates for Rate or Rhythm control drug therapy for AF 7. Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis 8. Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy 9. Creatinine clearance \<30ml/min or \>95ml/min 10. 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 11. Recent stroke (\<3 months) or thromboembolic event, transient ischemic attack or carotid angioplasty in the prior 3 months 12. Recent (\<3 months) intracranial or other major bleeding event 13. Candidates for heart or any other organ transplantation or left ventricular assist devices, recent (\< 3 months) valve or other cardiac surgery 14. Patients requiring ACE inhibitor or ARB drug therapy for any reason 15. History of hypersensitivity to antiarrhythmic drugs 16. Patients with other clinically significant medical condition that precludes study participation 17. Patients with life expectancy \< 1 year 18. 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. 19. Pregnant or nursing lactating mothers or women of childbearing potential who are not on effective contraceptive therapy 20. 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.

Inclusion Criteria

Exclusion Criteria

1. Subjects must be willing and able to give written informed consent
2. 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.
3. Subjects must have documented HFpEF \& paroxysmal or persistent AF and satisfy one of the following inclusion criteria a) Consecutive patients with AF, symptomatic heart failure requiring diuretic therapy for at least 30 days prior to study entry b) Hospitalization for HF and/or AF in the past 12 months prior to catheter ablation with documented NT-pro BNP \>200pg/ml for patients not in AF or \> 600 pg/ml for patients in AF on screening ECG or NYHA class 2, 3 or ambulatory class 4 heart failure documented NT-pro BNP \>300pg/ml for patients not in AF or \> 900 pg/ml for patients in AF on screening ECG c).Evidence of structural heart disease defined as by at least 1 of the following echocardiography findings (any local measurement made during the screening epoch or within the 6 months prior to screening visit): 1) LA enlargement defined by at least 1 of the following: LA width (diameter) \>3.8 cm or LA length \>5.0 cm or LA area \>20 cm2 or LA volume \>55 ml or LA volume index \>29 ml/m2 2) LVH defined by septal thickness or posterior wall thickness \>1.1 cm d).Left ventricular ejection fraction \> 45% using standard imaging techniques at enrollment for study or in prior 6 months e).ECG documented paroxysmal or persistent atrial fibrillation f).Patients are candidates for a clinically indicated catheter ablation procedure, and Rate or Rhythm control antiarrhythmic drug therapy
4. 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
5. Written informed consent for the clinically indicated study procedures
6. 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.

1. 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
2. Patients with QRS duration of \>120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy
3. Recent (\<1 month) myocardial infarction or acute coronary syndrome
4. Recent (\<3 months) coronary revascularization procedures
5. Documented LA thrombus on TEE or any LVEF measurement \<40%
6. Patients who are not candidates for Rate or Rhythm control drug therapy for AF
7. Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis
8. Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy
9. Creatinine clearance \<30ml/min or \>95ml/min
10. 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
11. Recent stroke (\<3 months) or thromboembolic event, transient ischemic attack or carotid angioplasty in the prior 3 months
12. Recent (\<3 months) intracranial or other major bleeding event
13. Candidates for heart or any other organ transplantation or left ventricular assist devices, recent (\< 3 months) valve or other cardiac surgery
14. Patients requiring ACE inhibitor or ARB drug therapy for any reason
15. History of hypersensitivity to antiarrhythmic drugs
16. Patients with other clinically significant medical condition that precludes study participation
17. Patients with life expectancy \< 1 year
18. 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.
19. Pregnant or nursing lactating mothers or women of childbearing potential who are not on effective contraceptive therapy
20. 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.

Contacts and Locations

Study Contact

SANJEEV SAKSENA, MD

CONTACT

7323029990

cmenj@aol.com

Carine Carvalhiero, BS

CONTACT

7323029990

eprf@aol.com

Principal Investigator

Sanjeev Saksena, MD

STUDY_CHAIR

Electrophysiology Research Foundation

Andrea Natale, MD

STUDY_DIRECTOR

Electrophysiology Research Foundation

Study Locations (Sites)

Northern Arizona Health Care

Flagstaff, Arizona, 86001

United States

St. Bernards Heart and Vascular Center

Jonesboro, Arkansas, 72401

United States

South Denver Cardiology

Littleton, Colorado, 80120

United States

Kansas City Heart Rhythm Institute

Overland, Missouri, 66211

United States

Electrophysiology Research Foundation

Warren, New Jersey, 07059

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

TCAI at St. David's Hospital

Austin, Texas, 78705

United States

Collaborators and Investigators

Sponsor: Electrophysiology Research Foundation

Sanjeev Saksena, MD, STUDY_CHAIR, Electrophysiology Research Foundation
Andrea Natale, MD, STUDY_DIRECTOR, Electrophysiology Research Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-26

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2020-07-26

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Atrial fibrillation
Heart failure
Diastolic heart failure
Catheter Ablation
Antiarrhythmic Drugs

Additional Relevant MeSH Terms

Atrial Fibrillation
Heart Failure
Diastolic Heart Failure