RECRUITING

Study of JK07 in Patients with Chronic Heart Failure

Conditions

Heart Failure with Reduced Ejection Fraction Heart Failure with Preserved Ejection Fraction Heart Failure Heart Failure NYHA Class III Heart Failure NYHA Class II Heart Failure with Atrial Fibrillation/Flutter HFrEF HFpEF Neuregulin 1 NRG-1 HER3 HER4 ErbB3 ErbB4 Systolic Heart Failure Diastolic Heart Failure Atrial Fibrillation Atrial Flutter

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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%.

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)

Quick Facts

Study Start:2024-03-28

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06369298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Amanda McEwen

CONTACT

888-521-8961

Info@SalubrisBio.com

Ashleigh Chasteen

CONTACT

888-521-8961

Info@Salubrisbio.com

Study Locations (Sites)

Site 121

Alexander City, Alabama, 35010

United States

Site 130

Birmingham, Alabama, 35211

United States

Site 138

Huntsville, Alabama, 35801

United States

Site 111

Phoenix, Arizona, 85016

United States

Site 127

Little Rock, Arkansas, 72205

United States

Site 128

Huntington Beach, California, 92648

United States

Site 116

Pasadena, California, 91105

United States

Site 129

Santa Maria, California, 93454

United States

Site 102

Stanford, California, 94305

United States

Site 113

Torrance, California, 90502

United States

Site 133

Vista, California, 92081

United States

Site 114

Hialeah, Florida, 33016

United States

Site 159

Naples, Florida, 34104

United States

Site 136

Atlanta, Georgia, 30343

United States

Site 143

Boise, Idaho, 83712

United States

Site 154

Park Ridge, Illinois, 60068

United States

Site 137

Fort Wayne, Indiana, 46804

United States

Site 112

Indianapolis, Indiana, 46250

United States

Site 104

Covington, Louisiana, 70433

United States

Site 119

Boston, Massachusetts, 02114

United States

Site 122

Bloomfield Hills, Michigan, 48304

United States

Site 150

Farmington Hills, Michigan, 48334

United States

Site 107

Rochester, Minnesota, 55905

United States

Site 106

Saint Louis, Missouri, 63110

United States

Site 105

Saint Louis, Missouri, 63136

United States

Site 144

Brick, New Jersey, 08724

United States

Site 117

Cincinnati, Ohio, 45219

United States

Site 100

Cleveland, Ohio, 44195

United States

Site 135

Oklahoma City, Oklahoma, 73135

United States

Site 110

Dallas, Texas, 75235

United States

Site 115

Dallas, Texas, 75246

United States

Site 103

Houston, Texas, 77030

United States

Site 149

Tomball, Texas, 77375

United States

Site 148

Arlington, Virginia, 22205

United States

Collaborators and Investigators

Sponsor: Salubris Biotherapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-03-28

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Heart Failure
Heart Failure with Reduced Ejection Fraction
Heart Failure with Preserved Ejection Fraction
Heart Failure NYHA Class III
Heart Failure NYHA Class II
Heart Failure with Atrial Fibrillation/Flutter
HFrEF
HFpEF
Neuregulin 1
NRG-1
HER3
HER4
ErbB3
ErbB4
Systolic Heart Failure
Diastolic Heart Failure
Atrial Fibrillation
Atrial Flutter

Additional Relevant MeSH Terms

Heart Failure with Reduced Ejection Fraction
Heart Failure with Preserved Ejection Fraction