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Can heart failure patients ditch their pills? new study aims to find out

NCT ID NCT07631156

Disease control Sponsor: Kyungsub Song Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This pilot study tests whether heart failure patients whose heart function has returned to normal can safely stop taking two medications (sacubitril/valsartan and dapagliflozin or empagliflozin). Eighty adults whose heart failure was caused by a treatable condition like a heart valve problem will be randomly assigned to either stop these drugs step-by-step or continue taking them. The main goal is to see if their heart function stays stable over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stepwise withdrawal of sacubitril/valsartan (ARNI) and dapagliflozin or empagliflozin (SGLT2i)
What this could lead to
If successful, this could show that some heart failure patients who have recovered may be able to safely reduce their medication burden without their heart function worsening.
What could go wrong
This is a small, early pilot study with only 80 participants, so results may not apply to everyone. There is a risk that stopping these medications could cause heart function to decline or lead to hospitalization.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 19 years or older * Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (normalized range) at the time of enrollment * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \<250 ng/L * Complete correction of a reversible underlying cause of heart failure: surgical or transcatheter correction of valvular heart disease (mitral regurgitation, aortic stenosis, aortic regurgitation), or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ischemic cardiomyopathy * Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and/or beta-blocker may also be used) * Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months * Able to provide written informed consent Exclusion Criteria: * Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy) * For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation * For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT * Chronic kidney disease stage 4 or higher (eGFR \<30 mL/min/1.73 m²) * Symptomatic hypotension (systolic blood pressure \<90 mmHg) or symptomatic bradycardia (heart rate \<50 beats/min) * Pregnant, suspected pregnancy, or breastfeeding * Terminal malignancy or end-stage organ failure with life expectancy \<12 months * Participation in another clinical trial within 3 months prior to screening * Any condition that, in the investigator's judgment, makes the participant unsuitable for the study

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Conditions

The condition(s) this trial relates to.

heart failure heart valve disorder left ventricular failure systolic heart failure Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Heart failure with reduced ejection fraction Ventricular dysfunction, left

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ajou University Hospital

    NOT_YET_RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, Daegu, 42601, South Korea

  • Korea University Anam Hospital

    NOT_YET_RECRUITING

    Seoul, Seoul, 02841, South Korea

  • Pusan National University Yangsan Hospital

    NOT_YET_RECRUITING

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Seoul National University Bundang Hospital

    NOT_YET_RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

More trials for these conditions

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