Tapering Heart Failure Medication in Patients With Heart Failure With Recovered Ejection Fraction; Open Label Prospective Random Trial (HFrecEF)

March 23, 2026 updated by: Chungnam National University Hospital

Study start date is on Nov 27th 2024.

A patient with an initial ejection fraction (EF) of less than 40%, whose follow-up shows an improvement to an EF of 50% or higher, along with the left ventricular end-diastolic diameter returning to the normal range and taking 3 more heart failure medication randomed to drug tapering group ( RAS blocker or beta blocker) or continuing medication group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients described above randomly assigned to drug tapering group and drug maintaining group.

Drug tapering group is 2 groups, which one is RAS blocker tapering group and others is beta blocker tapering group.

Drug tapering group is monitored ejection fraction, LV dimension and LV GLS by 1-3 month.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
    • Republic of Korea
      • Daejeon, Republic of Korea, South Korea, 35015
        • Recruiting
        • Chungnam national university hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • initial echocardiogram ejection fraction less than 40%
  • follow up echocardiogram ejection fraction over 50% and LVEDD index normal range

  • NTprobnp criteria

    1. eGFR ≥60 ; less 440
    2. eGFR 45-59: less 980
    3. eGFR 30-44; less 1220
    4. eGFR < 30 : less 5300
    5. in HD; no criteria for NTproBNP
  • on more than 3 heart failure medication ( RAS blocker, beta blocker, mineral corticoid receptor antagonist, SGLT 2 inhibitor)

Exclusion Criteria:

  1. under age 18 year
  2. uncontrolled BP ( over 150/90)
  3. coronary revascularization within 6 months
  4. significant valve disease
  5. arrhythmia requiring rate control
  6. CKD with albuminuria ( over 30mg/g)
  7. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RAS blocker tapering arm
RAS blocker tapering
Drug: RAS blocker tapering group
RAS blocker tapering out
Drug: Beta blocker tapering out
Beta blocker tapering out group
Active Comparator: Beta blocker tapering arm
Drug: RAS blocker tapering group
RAS blocker tapering out
Drug: Beta blocker tapering out
Beta blocker tapering out group
Placebo Comparator: Control
Drug maintain group
Drug: RAS blocker tapering group
RAS blocker tapering out
Drug: Beta blocker tapering out
Beta blocker tapering out group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure relapse
Time Frame: From enrollment to the end of treatment at 18 months
LVEF 10% drop, EF less than 50 %, LVIDd/BSA 10% increase, over 33mm/m^2
From enrollment to the end of treatment at 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungnam National University Hospital

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 Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Actual)

May 26, 2025

Study Completion (Estimated)

November 26, 2027

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2024-09-039-002
  • 2024-09-039-002 (Other Identifier: Chungnam national university hospital IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Beginning 3 months after the publication of results with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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