Skip to main content
OpenTrials
Completed

NCT Number: NCT06017609

Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD, Burgas, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit;
  • Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit;
  • Is on stable, guideline-directed therapy for HF, consistent with American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);
  • Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;
  • Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit.

Exclusion criteria

  • Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;
  • Has a history of coronary revascularization (percutaneous coronary intervention [PCI] and/or coronary artery bypass graft [CABG]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit);
  • Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit;
  • Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;
  • Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;
  • Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation) at the Screening Visit.

Treatment and study plan

JTT-861 Capsules

Drug

Active drug capsules containing JTT-861

placebo capsules

Drug

Placebo capsules matching in appearance to the active drug capsules

Primary outcomes

  1. Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)

    Time frame: 12 Weeks

  2. Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo

    Time frame: 12 Weeks

  3. Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo

    Time frame: 12 Weeks

  4. Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo

    Time frame: 12 Weeks

  5. Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values

    Time frame: 12 Weeks

  6. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline

    Time frame: 16 Weeks

    General Scoring Guideline: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent

  7. Number of subjects with treatment-emergent adverse events

    Time frame: Up to 16 Weeks

  8. Trough plasma concentrations of JTT-861

    Time frame: Weeks 4, 8 and 12

  9. Post-dose plasma concentrations of JTT-861

    Time frame: Weeks 2, 4 and 8

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study title

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of JTT-861 Administered for 12 Weeks in Subjects With Heart Failure With Reduced Ejection Fraction

Acronym: POWER-HF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.