RECRUITING

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

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Conditions

Chronic Heart FailureJTT-861EfficacySafetyTolerabilityHFrEFHeart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-12-20
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06017609

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.

Ages Eligible for Study:30 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit;
  2. * Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit;
  3. * 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);
  4. * Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;
  5. * 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.
  1. * Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;
  2. * 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);
  3. * 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;
  4. * Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;
  5. * Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;
  6. * 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.

Contacts and Locations

Study Contact

Takanori Nemoto, M.S.
CONTACT
609-919-9570
ClinicalTrials@akrospharma.com
Kala Patel, R.Ph., RAC
CONTACT
609-919-6131
ClinicalTrials@akrospharma.com

Study Locations (Sites)

Nature Coast Clinical Research
Crystal River, Florida, 34429
United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
United States
Pharma Medical Innovation, Inc.
Miami Lakes, Florida, 33014
United States
D and H Tamarac Research Center, LLC
Tamarac, Florida, 33321
United States
Affinity Health
Park Ridge, Illinois, 60068
United States
ASHA Clinical Research-Munster, LLC
Hammond, Indiana, 46324
United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301
United States
Monroe Research, LLC
West Monroe, Louisiana, 71291
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Laurelton Heart Specialist P.C.
Rosedale, New York, 11422
United States
Medication Management, LLC
Greensboro, North Carolina, 27405
United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
United States
Onsite Clinical Solutions, LLC
Rock Hill, South Carolina, 29732
United States
Prime Revival Research Institute, LLC
Coppell, Texas, 75019
United States
Cypress Heart and Vascular Center
Cypress, Texas, 77429
United States
East Texas Cardiology PA
Houston, Texas, 77002
United States
Sherman Clinical Research
Sherman, Texas, 75092
United States
Waco Cardiology Associates - NextStage Clinical Research
Waco, Texas, 76712
United States

Collaborators and Investigators

Sponsor: Akros Pharma Inc.

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 Registration Dates

Study Start Date2023-12-20
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • JTT-861
  • Efficacy
  • Safety
  • Tolerability
  • Chronic Heart Failure
  • HFrEF
  • Heart Failure

Additional Relevant MeSH Terms

  • Chronic Heart Failure