protocolSection identificationModule nctId: NCT06369298, orgStudyIdInfo id: JK07.2.01, briefTitle: Study of JK07 in Patients With Chronic Heart Failure, acronym: RENEU-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Salubris Biotherapeutics Inc, class: INDUSTRY, descriptionModule briefSummary: 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%.Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 282, type: ESTIMATED, armsInterventionsModule interventions name: JK07, interventions name: Placebo, outcomesModule primaryOutcomes measure: Safety - Cohort 1, primaryOutcomes measure: Efficacy - Cohort 1, primaryOutcomes measure: Safety - Cohort 2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern California Heart Specialists, status: RECRUITING, city: Pasadena, state: California, zip: 91105, country: United States, contacts name: Gregory Giesler, role: CONTACT, geoPoint lat: 34.14778, lon: -118.14452, locations facility: New Generation of Medical Research, status: RECRUITING, city: Hialeah, state: Florida, zip: 33016, country: United States, contacts name: Karelia Ruiz, role: CONTACT, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Louisiana Heart Center, status: RECRUITING, city: Covington, state: Louisiana, zip: 70433, country: United States, contacts name: Bruce Iteld, MD, role: CONTACT, geoPoint lat: 30.47549, lon: -90.10042, locations facility: Cardiology and Vascular Associates, status: RECRUITING, city: Bloomfield Hills, state: Michigan, zip: 48304, country: United States, contacts name: Kirit Patel, role: CONTACT, geoPoint lat: 42.58364, lon: -83.24549, locations facility: St. Louis Heart and Vascular Cardiology, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63136, country: United States, contacts name: Harvey Serota, role: CONTACT, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Southwest Family Medicine, status: RECRUITING, city: Dallas, state: Texas, zip: 75235, country: United States, contacts name: Chriistte Dharma, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False