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PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Tamibarotene for HFpEF - Heart Failure With Preserved Ejection Fraction

This study will measure the effect of 12 weeks of treatment with tamibarotene compared with dummy treatment (placebo) on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with heart failure with preserved ejection fraction (HFpEF).

Official registry: https://clinicaltrials.gov/study/NCT07855692 · Nagoya University · enrollment listed as 90

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

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 Tamibarotene, or Placebo. The registry lists allocation as randomized. This study will measure the effect of 12 weeks of treatment with tamibarotene compared with dummy treatment (placebo) on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with heart failure with preserved ejection fraction (HFpEF).

They plan to enroll about 90 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Trial: The Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Low-dose Tamibarotene on Improving NT-proBNP in Patients With Heart Failure With Preserved Ejection Fraction (RELIEF Trial)

Interventions: Tamibarotene, Placebo

Primary outcome (registry wording): Change From Baseline in serum NT-proBNP

Who it is for (from inclusion criteria)

  • Ages 26 Years to any
  • 2\. Patients with LVEF of 50% or more as determined by echocardiography at screening
  • 3\. Patients with an NT-proBNP level of 300 pg/mL or more at screening (or 600 pg/mL or more for patients with atrial fibrillation at screening)
  • 5\. Patients receiving any of the following medications whose dosage regimen has remained unchanged for at least 4 weeks prior to the initiation of investigational product administration:
  • ・Diuretics,SGLT2 inhibitors, ARNIs, ARBs, ACE inhibitors, MRAs, beta-blockers, digitalis preparations, HCN channel blockers, Soluble guanylate cyclase stimulators
  • 6\. Patients with eGFR of 30 mL/min/1.73 m² or more at screening
  • 7\. Patients with a body-mass index (BMI) of less than 45 kg/m² at screening
  • 9\. Patients who agree to comply with the applicable requirement(s) below:

Public study contact (from the registry)

Katsuhiro Kato, M.D. Ph.D.

+81 52 744 2150

kato.katsuhiro.x2@f.mail.nagoya-u.ac.jp

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

Sites listed on ClinicalTrials.gov

4 listed

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FAQ about this NCT record

Is NCT07855692 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 NCT07855692?

Phase 2. 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 NCT07855692?

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