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A Phase 2 Randomized, Double-blind, Placebo-controlled Study

UCI Specialty Area: Cardiology
Principal Investigator: Felice Lin
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)
A Study On:
Heart - Cardiovascular Circulatory
Heart Failure

Study Description

Eligibility

  1. Participants with New York Heart Association (NYHA) Class II-III.
  2. Cohort 1 - Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%.
  3. Cohort 2 - Left Ventricular Ejection Fraction (LVEF) greater than 40% and less than or equal to 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) greater than or equal to 600pg/mL and atrial fibrillation/flutter.
  4. Stable heart failure and on optimal medical therapy.
  5. Screening hemoglobin greater than or equal to 9.0 g/dL.
  1. Uncontrolled hypertension.
  2. Sustained systolic Blood Pressure (BP) less than 90 mmHg and/or diastolic BP less than 50 mmHg on 2 consecutive (duplicate seated) readings at screening.
  3. 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.
  4. Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy.
  5. Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.
  6. Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening.
  7. History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator.
  8. Moderate or severe aortic and/or mitral valve stenosis.
  9. 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 prior to start of screening.
  10. Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
  11. Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate greater than 110 beats per minute at screening.
  12. For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is greater than or equal to 2 in men or greater than or equal to 3 in women or per local guidelines. Percutaneous occlusion of the left atrial appendage alone is not adequate.
  13. AF ablation within the last 12 weeks prior to screening or planned during the study duration.
  14. Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker.
  15. Cardiac surgery, coronary artery revascularization or indication for coronary artery revascularization, percutaneous coronary intervention, valve repair/replacement or valvuloplasty within 12 weeks prior to screening.
  16. Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeks prior to screening, or intent to implant a CRT device during the course of the study.
  17. Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization.
  18. Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening.
  19. Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening.
  20. Receiving IV vasodilators within the last 4 weeks prior to screening.
  21. Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
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    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies.