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Clinical trialNCT04160000UnknownPhase 4Interventional

Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

SponsorElectrophysiology Research FoundationEnrollment360Atrial FibrillationDiastolic Heart FailureHeart Failure
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany
  • Peter Osypka Herzzentrum

    Munich, Bavaria, Germany

    Not, yet, recruiting
Switzerland
  • Hopitaux Universitaires de Geneve

    Geneva, Canton of Geneva, Switzerland

    Recruiting
United States
  • Northern Arizona Health Care

    Flagstaff, Arizona, United States

    Rangadham Nagarakanti
    Recruiting
  • St. Bernards Heart and Vascular Center

    Jonesboro, Arkansas, United States

    Recruiting
  • South Denver Cardiology

    Littleton, Colorado, United States

    Recruiting
  • Kansas City Heart Rhythm Institute

    Overland, Missouri, United States

    Rakesh Gopinathannair, MD
    Recruiting
  • Electrophysiology Research Foundation

    Warren Township, New Jersey, United States

    Atul Prakash, MDSanjeev Saksena, MD
    Recruiting
  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States

    Recruiting
  • Tcai at St. David'S Hospital

    Austin, Texas, United States

    Mary B Cishek, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Empiric heart failure drug therapyRate or Rhythm control antiarrhythmic drugs for atrial fibrillation
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
26 Jul 2020
Primary completion
31 Dec 2024
Completion
30 Jun 2025
Last update posted
23 May 2024
Registered enrollment
360
Registry id
NCT04160000

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.