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

May 21, 2026 updated by: Akros Pharma Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD
      • Gotse Delchev, Bulgaria, 2900
        • Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD
      • Gotse Delchev, Bulgaria, 2900
        • Multiprofile Hospital for Active Treatment "Ivan Skenderov"
      • Pleven, Bulgaria, 5804
        • Multiprofile Hospital for Active Treatment Heart and Brain EAD
      • Pleven, Bulgaria, 5803
        • University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital For Active Treatment Saint Georgi EAD
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1415
        • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
      • Sofia, Bulgaria, 1527
        • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultative Center Convex EOOD
      • Sofia, Bulgaria, 1750
        • University Multiprofile Hospital for Active Treatment. Sv Anna - Sofia AD
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni Nemocnice Brno
      • Brno, Czechia, 602 00
        • MUDr. Libor Nechvatal s.r.o.
      • Brno, Czechia, 603 00
        • Centrum pro zdraví, s.r.o.
      • Brno, Czechia, 615 00
        • Vojenska nemocnice Brno
      • Broumov, Czechia, 550 01
        • EDUMED s.r.o.
      • Hradec Králové, Czechia, 500 02
        • EDUMED s.r.o.
      • Jaroměř, Czechia, 551 01
        • EDUMED s.r.o.
      • Náchod, Czechia, 547 01
        • EDUMED s.r.o.
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni nemocnice Ostrava
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny W Bialymstoku
      • Chrzanów, Poland, 32-500
        • American Heart of Poland S.A.
      • Dąbrowa Górnicza, Poland, 41-300
        • American Heart of Poland S.A.
      • Katowice, Poland, 40-555
        • Kardio Brynów Sp. z o.o.
      • Kędzierzyn-Koźle, Poland, 47-200
        • Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
      • Lublin, Poland, 20-090
        • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
      • Piotrkow Trybunalski, Poland, 97-300
        • Trialmed CRS Piotrków Trybunalski
      • Sopot, Poland, 81-717
        • NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus
      • Tychy, Poland, 43-100
        • American Heart of Poland S.A.
      • Wroclaw, Poland, 53-114
        • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
  • Romania
      • Brasov, Romania, 500326
        • Spitalul Clinic Judetean de Urgenta Brasov
      • Brasov, Romania, 500102
        • Thera Card S.R.L
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucharest, Romania, 021659
        • Spitalul Clinic De Urgență Sf. Pantelimon București
      • Buzău, Romania, 120133
        • Mat Cord Biomedica SRL
      • Cluj-Napoca, Romania, 400015
        • Angiocare S.R.L.
      • Craiova, Romania, 200642
        • Spitalul Clinic Judetean De Urgenta Craiova
      • Craiova, Romania, 200513
        • Cardio Med SRL
      • Timișoara, Romania, 300079
        • Spitalul Clinic Municipal de Urgenta Timisoara
      • Timișoara, Romania, 300024
        • Spitalul Clinic Municipal de Urgenta Timisoara
      • Târgu Mureş, Romania, 540124
        • Cardio Med SRL
      • Târgu Mureş, Romania, 540143
        • CMI Dr. Podoleanu Cristian
  • Spain
      • A Coruña, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Barcelona, Spain, 08003
        • Hospital del Mar - Parc de Salut Mar
      • Ferrol, Spain, 15405
        • Area Sanitaria De Ferrol - Hospital Arquitecto Marcide
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundación Jimenez Díaz
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de La Arrixaca
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Arensia Exploratory Medicine Inc.
    • Florida
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc.
      • Miami, Florida, United States, 33186
        • Med Research of Florida
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research
      • Miami Lakes, Florida, United States, 33014
        • Pharma Medical Innovation, Inc.
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Affinity Health
    • Indiana
      • Hammond, Indiana, United States, 46324
        • ASHA Clinical Research-Munster, LLC
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Monroe Research, LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Farmington Hills, Michigan, United States, 48334
        • Profound Research LLC
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • NextStage Clinical Research - (Kansas City [01])
    • New York
      • Rosedale, New York, United States, 11422
        • Laurelton Heart Specialist P.C.
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Onsite Clinical Solutions, LLC
    • Texas
      • Beaumont, Texas, United States, 77702
        • NextStage Clinical Research-Beaumont- (01)
      • Cypress, Texas, United States, 77429
        • Cypress Heart and Vascular Center
      • Port Arthur, Texas, United States, 77642
        • NextStage Clinical Research-Port Arthur-(02)
      • Sherman, Texas, United States, 75092
        • Sherman Clinical Research
      • Waco, Texas, United States, 76712
        • Waco Cardiology Associates - NextStage Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JTT-861 Dose 1
JTT-861 Capsules Dose 1 orally once daily for 12 weeks
Drug: JTT-861 Capsules
Active drug capsules containing JTT-861
Experimental: JTT-861 Dose 2
JTT-861 Capsules Dose 2 orally once daily for 12 weeks
Drug: JTT-861 Capsules
Active drug capsules containing JTT-861
Experimental: Placebo
Placebo Capsules orally once daily for 12 weeks
Drug: Placebo Capsules
Placebo capsules matching in appearance to the active drug capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 Weeks
Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
Time Frame: 12 Weeks
12 Weeks
Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
Time Frame: 12 Weeks
12 Weeks
Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
Time Frame: 12 Weeks
12 Weeks
Number of subjects with treatment-emergent adverse events
Time Frame: Up to 16 Weeks
Up to 16 Weeks
Trough plasma concentrations of JTT-861
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Post-dose plasma concentrations of JTT-861
Time Frame: Weeks 2, 4 and 8
Weeks 2, 4 and 8
Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values
Time Frame: 12 Weeks
12 Weeks
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
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akros Pharma Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ICON Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT861-G-22-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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