Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Stepwise Withdrawal of ARNI and SGLT2i for Heart Failure With Reduced Ejection Fraction

This is a multicenter, randomly assigned, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention. Eighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is ≤ 250 ng/L will be randomly assigned 1:1 to either (1) stepwise withdrawal of ARNI followed by SGLT2i over one month under close echocardiographic monitoring, or (2) continuation of their current guideline-directed medical therapy.

Official registry: https://clinicaltrials.gov/study/NCT07631156 · Kyungsub Song · enrollment listed as 80

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Stepwise Withdrawal of ARNI and SGLT2i, or Continued Guideline-Directed Medical Therapy. The registry lists allocation as randomized. This is a multicenter, randomly assigned, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention.

They plan to enroll about 80 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure (STEP-DOWN HF Trial)

Interventions: Stepwise Withdrawal of ARNI and SGLT2i, Continued Guideline-Directed Medical Therapy

Primary outcome (registry wording): Change in Left Ventricular Ejection Fraction (LVEF) at 12 Months

Who it is for (from inclusion criteria)

  • Ages 19 Years to any
  • 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
  • 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

Public study contact (from the registry)

Kyungsub Song, Professor

82)1065564907

chest.songks@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT07631156 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07631156?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07631156?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary