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Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

NCT06898515 · Reprieve Cardiovascular, Inc
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Official title
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
About this study
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.
Eligibility criteria
Inclusion Criteria: 1. Diagnosis of HF with expected hospitalization \>24 hours, with \>1 new or worsening symptom and \>2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment 2. ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider. 3. Current outpatient prescription for daily loop diuretic. 4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures. 5. Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \<1L in the 6 hours following IV loop diuretic \>=40 mg furosemide equivalent OR Spot urine sodium \<100 mmol/L 1-2 hours after IV loop diuretic \>= 40 mg furosemide equivalent Exclusion Criteria: 1. Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter. 2. Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \<90 mmHg for \>15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week. 3. Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours. 4. Severe lung disease with chronic home oxygen requirement \>2L/min. 5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count). 6. Estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT). 7. Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe. 8. Current or recent (\< 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion. 9. Severe electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial. 10. Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy 11. Currently enrolled in an interventional trial (observational studies are permitted). 12. Life expectancy less than 6 months. 13. Women who are pregnant or breastfeeding.
Study design
Enrollment target: 400 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-07-14
Estimated completion: 2027-12
Last updated: 2025-11-26
Interventions
Device: Reprieve SystemDrug: furosemide infusion
Primary outcomes
  • Hierarchical composite/win-ratio (1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization)
  • Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI) (initiation of randomized therapy through 72 hours following completion of randomized therapy)
Sponsor
Reprieve Cardiovascular, Inc · industry
Contacts & investigators
ContactAnnemarie Forrest · contact · aforrest@reprievecardio.com · 617-848-0400
InvestigatorJaved Butler, MD, MPH, MBA · principal_investigator, Baylor Scott and White Health
All locations (53)
University of California IrvineRecruiting
Irvine, California, United States
Scripps Memorial HospitalNot Yet Recruiting
La Jolla, California, United States
UC Davis Medical CenterRecruiting
Sacramento, California, United States
University of FloridaRecruiting
Gainesville, Florida, United States
Piedmont Atlanta HospitalRecruiting
Atlanta, Georgia, United States
Piedmont Augusta HospitalRecruiting
Augusta, Georgia, United States
Northeast Georgia Medical CenterRecruiting
Gainesville, Georgia, United States
Advocate Christ Medical CenterNot Yet Recruiting
Oak Lawn, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
University of Louisville HospitalNot Yet Recruiting
Louisville, Kentucky, United States
Trinity Health Ann Arbor HospitalRecruiting
Ann Arbor, Michigan, United States
Corewell Health Butterworth HospitalRecruiting
Grand Rapids, Michigan, United States
Corewell William Beaumont University HospitalRecruiting
Royal Oak, Michigan, United States
Minneapolis Heart InstituteRecruiting
Minneapolis, Minnesota, United States
University of MississippiRecruiting
Jackson, Mississippi, United States
Harry S. Truman Veteran's Memorial HospitalNot Yet Recruiting
Columbia, Missouri, United States
St. Louis VARecruiting
St Louis, Missouri, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Stony Brook University HospitalRecruiting
Stony Brook, New York, United States
Duke UniversityNot Yet Recruiting
Durham, North Carolina, United States
Moses H. Cone Memorial HospitalNot Yet Recruiting
Greensboro, North Carolina, United States
Atrium Health Wake Forest Baptist Medical CenterRecruiting
Winston-Salem, North Carolina, United States
Lindner Center at Christ HospitalRecruiting
Cincinnati, Ohio, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
UH Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Ohio State University HospitalRecruiting
Columbus, Ohio, United States
Oklahoma Heart HospitalRecruiting
Oklahoma City, Oklahoma, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Prisma Health Greenville Memorial HospitalRecruiting
Greenville, South Carolina, United States
Baylor Scott and WhiteRecruiting
Dallas, Texas, United States
Baylor College of Medicine Ben Taub HospitalRecruiting
Houston, Texas, United States
Memorial Hermann-Texas Medical CenterRecruiting
Houston, Texas, United States
Inova Fairfax Medical CampusRecruiting
Falls Church, Virginia, United States
VCU Medical CenterRecruiting
Richmond, Virginia, United States
UW HarborviewRecruiting
Seattle, Washington, United States
Aurora St. Luke's Medical CenterNot Yet Recruiting
Milwaukee, Wisconsin, United States
Universitätsklinikum Gießen (UKGM)Recruiting
Giessen, Germany
Hannover University HospitalRecruiting
Hanover, Germany
University Hospital HeidelbergRecruiting
Heidelberg, Germany
Jena University HospitalNot Yet Recruiting
Jena, Germany
Universitaria delle MarcheNot Yet Recruiting
Ancona, Italy
ASST Azienda Ospedaliera Papa Giovanni XXIIINot Yet Recruiting
Bergamo, Italy
ASST Niguarda Great Metropolitan HospitalNot Yet Recruiting
Milan, Italy
Medical University of BiałystokRecruiting
Bialystok, Poland
Medical University of LodzRecruiting
Lodz, Poland
University Hospital WroclawRecruiting
Wroclaw, Poland
Vall d'Hebron University HospitalRecruiting
Barcelona, Spain
Hospital de BellvitgeRecruiting
Barcelona, Spain
Hospital Ramon y CajalRecruiting
Madrid, Spain
Puerta de Hierro Majadahonda University HospitalRecruiting
Madrid, Spain
Clínico Universitario de ValenciaRecruiting
Valencia, Spain
Hospital General ValenciaRecruiting
Valencia, Spain
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258) · TrialPath