nctId: NCT06264310 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) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-03 date: 2024-02-16 date: 2024-02-20 name: River 2 Renal Corp. class: INDUSTRY name: International HealthCare, LLC 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) conditions: Heart Failure conditions: Worsening Heart Failure (WHF) studyType: INTERVENTIONAL phases: PHASE2 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 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 count: 32 type: ESTIMATED name: Placebo name: R2R01 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. 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. measure: Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30. measure: Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30. measure: Number of patients requiring dose adjustment of oral diuretics during the 30-day follow-up. 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. measure: Number of cardiovascular hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of patients with CV mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of patients with all-cause mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Shore Research Institute city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: C&R Research Services USA, Inc. city: Cape Coral state: Florida zip: 33904 country: United States lat: 26.56285 lon: -81.94953 facility: Nature Coast Clinical Research city: Inverness state: Florida zip: 34452 country: United States lat: 28.83582 lon: -82.33037 facility: Jacksonville Center for Clinical Research city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: Amavita Research Services, LLC city: Miami state: Florida zip: 33137 country: United States lat: 25.77427 lon: -80.19366 hasResults: False