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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Ejection Fraction; Recovery of Function
• Interventions: Drug: RAS blocker tapering group; Drug: Beta blocker tapering out

• Registration Number: NCT06724653
• Lead Sponsor: Chungnam National University Hospital

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-12-06
• Primary Completion: 2026-11-26
• Study Completion: 2027-11-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAS blocker tapering arm	RAS blocker tapering group	RAS blocker tapering
RAS blocker tapering arm	Beta blocker tapering out	RAS blocker tapering
Beta blocker tapering arm	RAS blocker tapering group	Beta blocker tapering arm
Beta blocker tapering arm	Beta blocker tapering out	Beta blocker tapering arm
Control	Beta blocker tapering out	Drug maintain group
Control	RAS blocker tapering group	Drug maintain group

Primary Outcome Measures

Name	Time	Method
Heart failure relapse	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