Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced… (NCT06017609) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
United States314 participantsStarted 2023-12-20
Plain-language summary
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.
Who can participate
Age range30 Years – 85 Years
SexALL
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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 clinica…
What they're measuring
1
Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)
Timeframe: 12 Weeks
2
Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
Timeframe: 12 Weeks
3
Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
Timeframe: 12 Weeks
4
Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
Timeframe: 12 Weeks
5
Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values
Timeframe: 12 Weeks
6
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline
Timeframe: 16 Weeks
7
Number of subjects with treatment-emergent adverse events