Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
NCT ID: NCT06898515
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-07-14
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Reprieve System
Participants randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
Reprieve System
The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
Optimal Diuretic Therapy (ODT)
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
furosemide infusion
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
Registry
Participants will be treated per local site usual care.
No interventions assigned to this group
Interventions
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Reprieve System
The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
furosemide infusion
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Reprieve Cardiovascular, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Javed Butler, MD, MPH, MBA
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health
Locations
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University of California Irvine
Irvine, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Piedmont Augusta Hospital
Augusta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan, United States
Corewell Health Butterworth Hospital
Grand Rapids, Michigan, United States
Corewell William Beaumont University Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Mississippi
Jackson, Mississippi, United States
Harry S. Truman Veteran's Memorial Hospital
Columbia, Missouri, United States
St. Louis VA
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Duke University
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Lindner Center at Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Baylor Scott and White
Dallas, Texas, United States
Baylor College of Medicine Ben Taub Hospital
Houston, Texas, United States
Memorial Hermann-Texas Medical Center
Houston, Texas, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
UW Harborview
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Universitätsklinikum Gießen (UKGM)
Giessen, , Germany
Hannover University Hospital
Hanover, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Jena University Hospital
Jena, , Germany
Universitaria delle Marche
Ancona, , Italy
ASST Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
ASST Niguarda Great Metropolitan Hospital
Milan, , Italy
Medical University of Białystok
Bialystok, , Poland
Medical University of Lodz
Lodz, , Poland
University Hospital Wroclaw
Wroclaw, , Poland
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital de Bellvitge
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Puerta de Hierro Majadahonda University Hospital
Madrid, , Spain
Clínico Universitario de Valencia
Valencia, , Spain
Hospital General Valencia
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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IDE-G210258-CLN0002
Identifier Type: -
Identifier Source: org_study_id
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