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

Launched by AKROS PHARMA INC. · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called JTT-861 to see how well it works, how safe it is, and how the body handles it in people with chronic heart failure, specifically those with a condition known as heart failure with reduced ejection fraction (HFrEF). The trial is open to adults aged 18 and older who have been diagnosed with heart failure for at least 90 days and are currently receiving stable heart failure treatments as recommended by health guidelines. To qualify, participants need to have specific heart function measurements, including a left ventricular ejection fraction (LVEF) of 35% or less and certain levels of a heart-related substance in their blood.

Participants in the trial will take JTT-861 once a day for 12 weeks. Throughout the study, they will have regular check-ups to monitor their health and response to the medication. It’s important to note that individuals with certain heart conditions or those who have recently undergone heart surgeries will not be eligible for this study. This trial aims to provide valuable information that could help improve treatment options for people with heart failure.

Gender

ALL

Eligibility criteria

• 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.