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

NCT ID: NCT06724653

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-06

Study Completion Date

2027-11-26

Brief Summary

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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

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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.

Conditions

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Heart Failure Ejection Fraction Recovery of Function

Keywords

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heart failure with recovered ejection fraction Tapering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomly assignment to 3 groups ( drug tapering\_RAS blocker, beta blocker, drug maintaining)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RAS blocker tapering arm

RAS blocker tapering

Group Type ACTIVE_COMPARATOR

RAS blocker tapering group

Intervention Type DRUG

RAS blocker tapering out

Beta blocker tapering out

Intervention Type DRUG

Beta blocker tapering out group

Beta blocker tapering arm

Beta blocker tapering arm

Group Type ACTIVE_COMPARATOR

RAS blocker tapering group

Intervention Type DRUG

RAS blocker tapering out

Beta blocker tapering out

Intervention Type DRUG

Beta blocker tapering out group

Control

Drug maintain group

Group Type PLACEBO_COMPARATOR

RAS blocker tapering group

Intervention Type DRUG

RAS blocker tapering out

Beta blocker tapering out

Intervention Type DRUG

Beta blocker tapering out group

Interventions

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RAS blocker tapering group

RAS blocker tapering out

Intervention Type DRUG

Beta blocker tapering out

Beta blocker tapering out group

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chungnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Yujin Yang

Role: CONTACT

Phone: 821043311245

Email: [email protected]

Other Identifiers

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2024-09-039-002

Identifier Type: OTHER

Identifier Source: secondary_id

IRB 2024-09-039-002

Identifier Type: -

Identifier Source: org_study_id