Tapering Heart Failure Medication in Patients With Heart Failure With Recovered Ejection Fraction; Open Label Prospective Random Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RAS blocker tapering group, Beta blocker tapering out.
- Who it may be relevant to
- Registry conditions: Heart Failure, Ejection Fraction, Recovery of Function. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug RAS blocker tapering group
RAS blocker tapering out - Drug Beta blocker tapering out
Beta blocker tapering out group
Primary outcome measures
- Heart failure relapse [Time frame: From enrollment to the end of treatment at 18 months]
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
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 2 centers
- Jeonbuk national university hospital — Jeonju
- Chungnam national university hospital — Daejeon
Identifiers
NCT: NCT06724653 · IRB 2024-09-039-002 · 2024-09-039-002