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JTT-861 for Heart Failure (POWER-HF Trial)

Phase 2

Recruiting

Research Sponsored by Akros Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4, 8 and 12

Awards & highlights

POWER-HF Trial Summary

This trial will study a new drug to treat HFrEF, assessing safety, effectiveness, and how it works in the body.

Who is the study for?

This trial is for people who have had heart failure symptoms for at least 90 days, are in NYHA class II or III, and have been on stable heart failure medication as per guidelines. They should also have a left ventricular ejection fraction of 35% or less and certain levels of NT-pro-BNP. People with recent heart attacks, unstable angina, recent or planned heart surgeries, severe kidney issues, or other specific cardiovascular conditions cannot participate.Check my eligibility

What is being tested?

The study tests JTT-861 capsules against placebo capsules over a period of 12 weeks to see if they're effective and safe for treating chronic heart failure with reduced ejection fraction (HFrEF). Participants must be on stable medical therapy according to current guidelines while taking part in the trial.See study design

What are the potential side effects?

While the side effects specific to JTT-861 aren't detailed here, common side effects from medications like this can include dizziness, changes in blood pressure or kidney function, gastrointestinal discomforts such as nausea or diarrhea, headache and potential allergic reactions.

POWER-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart condition limits my physical activity but I can still perform light tasks.

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I have been on a stable heart failure treatment for over 4 weeks, following major heart association guidelines.

POWER-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 8 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 4, 8 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+6 more

POWER-HF Trial Design

3Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Placebo Capsules orally once daily for 12 weeks

Group II: JTT-861 Dose 2Experimental Treatment1 Intervention

JTT-861 Capsules Dose 2 orally once daily for 12 weeks

Group III: JTT-861 Dose 1Experimental Treatment1 Intervention

JTT-861 Capsules Dose 1 orally once daily for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Capsules

2013

Completed Phase 3

~1790

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Akros Pharma Inc.Lead Sponsor

23 Previous Clinical Trials

2,457 Total Patients Enrolled

ICON Clinical ResearchIndustry Sponsor

49 Previous Clinical Trials

14,916 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligible age range for this experiment greater than 25 years?

"This particular research project is accepting people aged 30 to 85. There are a total of 25 trials for those under 18 and 750 studies that need the participation of adults over 65 years old."

Answered by AI

Is enrollment for this research study still available?

"Affirmative. The information available on clinicaltrials.gov confirm that this medical trial, first posted in August of 2023, is actively recruiting patients to participate. In total 300 individuals will be accepted into the study from one research site."

Answered by AI

What is the upper bound of patients enrolled in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting patients. It was first posted on August 28th 2023 and the latest update occurred on August 24th 2023; 300 participants are needed at 1 site for participation in the trial."

Answered by AI

Who can join this clinical investigation?

"Eligibility conditions for this medical study necessitate that participants have chronic heart failure and are aged between 30 to 85 years old. Approximately 300 individuals must be recruited in total."

Answered by AI

Has the FDA given a formal approval for JTT-861 Dose 1?

"Given the fact this is a Phase 2 trial (i.e. some safety data has been established, but efficacy remains unproven), JTT-861 Dose 1 was assigned a score of 2 by our assessment team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017609.