Tapering heart-failure medicines in people whose ejection fraction recovered

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

This study will test whether slowly reducing either an ACE/ARB/ARNI (RAS blocker) or a beta blocker is safe for people whose EF improved from under 40% to 50% or higher, have a normal left ventricular size, and are taking at least three heart-failure medicines.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chungnam National University Hospital (other)
• Locations: 2 sites (Jeonju, Jeollabuk-do and 1 other locations)
• Trial ID: NCT06724653 on ClinicalTrials.gov

What this trial studies

This is an open-label, prospective randomized trial that enrolls adults whose initial ejection fraction was <40% and later improved to ≥50% with normalized left ventricular end-diastolic diameter and who are taking three or more heart-failure medications. Eligible participants are randomized to continue all medications or to a drug-tapering strategy in which either the RAS blocker or the beta blocker is gradually reduced. The tapering arms are monitored with echocardiographic measures (EF, LV dimensions, and LV global longitudinal strain), NT-proBNP, and clinical assessment every 1–3 months with predefined thresholds to stop tapering and restart therapy. Key exclusion criteria include uncontrolled hypertension, recent coronary revascularization, significant valve disease, arrhythmia requiring rate control, albuminuric CKD, pregnancy, and specific NT-proBNP/renal function limits at screening.

Who should consider this trial

Good fit: Adults whose EF was <40% initially but later improved to ≥50% with normalized LV size, who are on three or more guideline heart-failure medications and meet the trial's NT-proBNP and kidney-function screening thresholds are ideal candidates.

Not a fit: Patients with persistent reduced EF, significant valve disease, uncontrolled blood pressure, recent coronary revascularization, arrhythmias requiring rate control, albuminuric CKD, or pregnancy are unlikely to benefit from this tapering approach.

Why it matters

Potential benefit: If successful, this approach could allow some patients to safely reduce one heart-failure medicine, lowering side effects and pill burden while maintaining recovered heart function.

How similar studies have performed: Prior trials such as TRED-HF showed many patients relapsed after complete withdrawal of therapy, so partial tapering of a single drug class is a more conservative method that has been less well studied.

Eligibility criteria

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

Where this trial is running

Jeonju, Jeollabuk-do and 1 other locations

• Jeonbuk national university hospital — Jeonju, Jeollabuk-do, South Korea (RECRUITING)
• Chungnam national university hospital — Daejeon, Republic of Korea, South Korea (RECRUITING)

Study contacts

• Study coordinator: Yujin Yang

Conditions: Heart Failure, Ejection Fraction, Recovery of Function, heart failure with recovered ejection fraction, Tapering