protocolSection identificationModule nctId: NCT06264310, orgStudyIdInfo id: R2R01-WHF-201, briefTitle: To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: River 2 Renal Corp., class: INDUSTRY, collaborators name: International HealthCare, LLC, descriptionModule briefSummary: This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF), conditionsModule conditions: Heart Failure, conditions: Worsening Heart Failure (WHF), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomly assigned to one of four cohorts. Three groups will receive R2R01, and one group will receive placebo., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Treatment of all cohorts will be double-blind (all patients, study staff, investigators and Sponsor). Site pharmacist is unblinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: R2R01, outcomesModule primaryOutcomes measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0., primaryOutcomes measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0., secondaryOutcomes measure: Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30., secondaryOutcomes measure: Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30., secondaryOutcomes measure: Number of patients requiring dose adjustment of oral diuretics during the 30-day follow-up., secondaryOutcomes measure: Number of patients with an event of: WHF-induced SDAC or other outpatient clinic visits requiring additional intensification of the therapy/IV loop diuretics using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of cardiovascular hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of patients with CV mortality using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of patients with all-cause mortality using descriptive and summary statistics for change from baseline by dose level at Day 30., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eastern Shore Research Institute, city: Fairhope, state: Alabama, zip: 36532, country: United States, geoPoint lat: 30.52297, lon: -87.90333, locations facility: C&R Research Services USA, Inc., city: Cape Coral, state: Florida, zip: 33904, country: United States, geoPoint lat: 26.56285, lon: -81.94953, locations facility: Nature Coast Clinical Research, city: Inverness, state: Florida, zip: 34452, country: United States, geoPoint lat: 28.83582, lon: -82.33037, locations facility: Jacksonville Center for Clinical Research, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Amavita Research Services, LLC, city: Miami, state: Florida, zip: 33137, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False