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

Chungnam National University Hospital

Status: Not yet enrolling

Conditions: Recovery of Function; Ejection Fraction; Heart Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06724653

IRB 2024-09-039-002

2024-09-039-002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

RAS blocker tapering arm

Active Comparator group

Description:

RAS blocker tapering

Treatment:

Drug: RAS blocker tapering group

Drug: Beta blocker tapering out

Beta blocker tapering arm

Active Comparator group

Description:

Beta blocker tapering arm

Treatment:

Drug: RAS blocker tapering group

Drug: Beta blocker tapering out

Control

Placebo Comparator group

Description:

Drug maintain group

Treatment:

Drug: RAS blocker tapering group

Drug: Beta blocker tapering out