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

NCT06724653 | Recruiting DMC

• 2 other identifiers: IRB 2024-09-039-0022024-09-039-002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ejection Fraction; Recovery of Function; Heart Failure

Keywords

heart failure with recovered ejection fraction; Tapering

Outcome Measures

Primary Outcomes (1)

• Heart failure relapse

  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

Study Arms (3)

RAS blocker tapering arm

ACTIVE COMPARATOR

RAS blocker tapering

Drug: RAS blocker tapering group; Drug: Beta blocker tapering out

Beta blocker tapering arm

ACTIVE COMPARATOR

Beta blocker tapering arm

Control

PLACEBO COMPARATOR

Drug maintain group

Interventions

RAS blocker tapering group DRUG

RAS blocker tapering out

RAS blocker tapering arm

Beta blocker tapering out DRUG

Beta blocker tapering out group

RAS blocker tapering arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• initial echocardiogram ejection fraction less than 40%
• follow up echocardiogram ejection fraction over 50% and LVEDD index normal range
• NTprobnp criteria
• eGFR ≥60 ; less 440
• eGFR 45-59: less 980
• eGFR 30-44; less 1220
• eGFR \< 30 : less 5300
• in HD; no criteria for NTproBNP
• on more than 3 heart failure medication ( RAS blocker, beta blocker, mineral corticoid receptor antagonist, SGLT 2 inhibitor)

You may not qualify if:

• under age 18 year
• uncontrolled BP ( over 150/90)
• coronary revascularization within 6 months
• significant valve disease
• arrhythmia requiring rate control
• CKD with albuminuria ( over 30mg/g)
• Pregnancy

Sponsors & Collaborators

• Chungnam National University Hospital: lead

Study Sites (2)

Jeonbuk national university hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Chungnam national university hospital

Daejeon, Republic of Korea, 35015, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Yujin Yang

CONTACT

821043311245; wjsdudtns9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomly assignment to 3 groups ( drug tapering\_RAS blocker, beta blocker, drug maintaining)

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: March 6, 2025
• Primary Completion: May 26, 2025
• Study Completion (Estimated): November 26, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months after the publication of results with no end date

Locations

KR (2)