Study of JK07 in Patients With Chronic Heart Failure (NCT06369298) | Clinical Trial Compass
RecruitingPhase 2
Study of JK07 in Patients With Chronic Heart Failure
United States282 participantsStarted 2024-03-28
Plain-language summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
There will be 2 cohorts in this study:
Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.
Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Participants with New York Heart Association (NYHA) Class II-III.
* Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%.
* Cohort 2 - Left Ventricular Ejection Fraction (LVEF) \>40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter.
* Stable heart failure and on optimal medical therapy.
* Screening hemoglobin ≥ 9.0 g/dL.
Exclusion Criteria:
* Uncontrolled hypertension.
* Sustained systolic Blood Pressure (BP) \< 90 mmHg and/or diastolic BP \< 50 mmHg on 2 consecutive (duplicate seated) readings at screening.
* Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result.
* Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy.
* Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.
* Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening.
* History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator.
* Moderate or severe aortic and/or mitral valve stenosis.
* Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks…