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Investigating JK07 for treating chronic heart failure

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)

Phase 2 Interventional Salubris Biotherapeutics Inc · NCT06369298

This study is testing a new treatment called JK07 to see if it can help people aged 18-85 with chronic heart failure feel better and improve their heart function.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment282 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorSalubris Biotherapeutics Inc Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations62 sites (Alexander City, Alabama and 61 other locations)
Trial IDNCT06369298 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the safety, tolerability, and efficacy of JK07 in patients aged 18-85 with chronic heart failure. Participants are randomized into two cohorts based on their left ventricular ejection fraction (LVEF): those with LVEF of 40% or less, and those with LVEF between 40% and 65%. The study is double-blind and placebo-controlled, ensuring that neither the participants nor the researchers know who receives the treatment or placebo. The trial aims to determine if JK07 can improve heart function and overall health in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-85 with chronic heart failure classified as NYHA Class II-III and specific LVEF criteria.

Not a fit: Patients with uncontrolled hypertension or specific types of cardiomyopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with chronic heart failure.

How similar studies have performed: While this approach is being tested in this trial, similar studies have shown promise in treating heart failure with novel therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 prior to start of screening.
* Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
* Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate \> 110 beats per minute at screening.
* 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 ≥ 2 in men or ≥ 3 in women or per local guidelines. Percutaneous occlusion of the left atrial appendage alone is not adequate.
* AF ablation within the last 12 weeks prior to screening or planned during the study duration.
* Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker.
* 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.
* 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.
* Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization.
* Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening.
* Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening.
* Receiving IV vasodilators within the last 4 weeks prior to screening.
* Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.

Where this trial is running

Alexander City, Alabama and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection FractionHeart FailureHeart Failure with Reduced Ejection FractionHeart Failure with Preserved Ejection FractionHeart Failure NYHA Class IIIHeart Failure NYHA Class IIHeart Failure with Atrial Fibrillation/Flutter
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.