Actively Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
Led by Reprieve Cardiovascular, Inc · Updated on 2025-11-26
400
Participants Needed
53
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the Reprieve System compared to Optimal Diuretic Therapy (ODT) in treating patients with acute decompensated heart failure (ADHF). The study aims to find out if the Reprieve System can decongest patients more efficiently than current standard therapy. This is a phase 3 clinical trial sponsored by Reprieve Cardiovascular, Inc. Participants will be randomly assigned to one of three groups: receiving treatment with the Reprieve System device, undergoing ODT with guided diuretic titration following ESC guidelines, or receiving usual care at the local site. The Reprieve System delivers personalized and automated infusions of the IV diuretic furosemide and saline based on real-time urine output. Treatments are monitored through the hospital stay, with average discharge readiness occurring around 5 days. During the study, participants will be closely monitored for fluid and sodium loss, weight changes, time on intravenous diuretics, and hospital length of stay. Researchers will also track heart failure rehospitalizations and cardiovascular mortality up to 90 days after discharge. Safety assessments include checking for adverse events like kidney injury, infections, electrolyte imbalances, and other complications. The total participation period includes hospital treatment and follow-up assessments extending up to three months after discharge.
CONDITIONS
Brief Title
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of heart failure with expected hospitalization over 24 hours, including new or worsening symptoms and clinical findings, and receiving or planned heart failure treatment
- At least 10 pounds (4.5 kg) above dry weight as estimated by healthcare provider
- Current outpatient prescription for daily loop diuretic
- Age 22 years or older, able to provide informed consent and comply with study procedures
- Elevated risk of diuretic resistance shown by low chloride levels, low urine output, or low urine sodium after IV loop diuretic administration
You will not qualify if you...
- Urologic issues that increase risk of trauma or infection with catheter placement or inability to place a Foley catheter
- Hemodynamic instability including low blood pressure, recent use of IV vasopressors or inotropes, or recent mechanical circulatory support
- Uncontrolled arrhythmias with high heart rate recently
- Severe lung disease requiring chronic oxygen over 2 liters per minute
- Acute infection with systemic symptoms like fever or high white blood cell count
- Very low kidney function or current renal replacement therapy
- Severe heart conditions making aggressive fluid removal unsafe
- Recent type I myocardial infarction, coronary surgery, or stroke within 30 days
- Severe electrolyte abnormalities on screening labs
- Other conditions or diseases making study compliance difficult or prolonged hospitalization expected
- Participation in another interventional trial
- Life expectancy less than 6 months
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 days or until discharge
Participants receive fluid management treatment using either the Reprieve System device or guided diuretic therapy according to standard guidelines during their hospital stay.
Daily visits during hospital stay
Duration - Up to 90 days after hospital discharge
Participants are monitored for safety and clinical outcomes following completion of treatment, including assessment of heart failure rehospitalizations and mortality.
Approximately 3 visits post-discharge
Trial Site Locations
Total: 53 locations
1
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
Scripps Memorial Hospital
La Jolla, California, United States, 92037
Not Yet Recruiting
3
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
5
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
6
Piedmont Augusta Hospital
Augusta, Georgia, United States, 30901
Actively Recruiting
7
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Actively Recruiting
8
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Not Yet Recruiting
9
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Actively Recruiting
10
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
11
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan, United States, 48197
Actively Recruiting
12
Corewell Health Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
13
Corewell William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
14
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
15
University of Mississippi
Jackson, Mississippi, United States, 38677
Actively Recruiting
16
Harry S. Truman Veteran's Memorial Hospital
Columbia, Missouri, United States, 65201
Not Yet Recruiting
17
St. Louis VA
St Louis, Missouri, United States, 63130
Actively Recruiting
18
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
19
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
20
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
21
Duke University
Durham, North Carolina, United States, 27710
Not Yet Recruiting
22
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Not Yet Recruiting
23
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
24
Lindner Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
25
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
26
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
27
Ohio State University Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
28
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
29
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 191904
Actively Recruiting
30
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
31
Baylor Scott and White
Dallas, Texas, United States, 75246
Actively Recruiting
32
Baylor College of Medicine Ben Taub Hospital
Houston, Texas, United States, 77030
Actively Recruiting
33
Memorial Hermann-Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
34
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
35
VCU Medical Center
Richmond, Virginia, United States, 23219
Actively Recruiting
36
UW Harborview
Seattle, Washington, United States, 98104
Actively Recruiting
37
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Not Yet Recruiting
38
Universitätsklinikum Gießen (UKGM)
Giessen, Germany, 35392
Actively Recruiting
39
Hannover University Hospital
Hanover, Germany, 30625
Actively Recruiting
40
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
41
Jena University Hospital
Jena, Germany, 07747
Not Yet Recruiting
42
Universitaria delle Marche
Ancona, Italy, 60121
Not Yet Recruiting
43
ASST Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
44
ASST Niguarda Great Metropolitan Hospital
Milan, Italy, 20162
Not Yet Recruiting
45
Medical University of Białystok
Bialystok, Poland, 15-089
Actively Recruiting
46
Medical University of Lodz
Lodz, Poland, 70445
Actively Recruiting
47
University Hospital Wroclaw
Wroclaw, Poland, 45573
Actively Recruiting
48
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
49
Hospital de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
50
Hospital Ramon y Cajal
Madrid, Spain, 28000
Actively Recruiting
51
Puerta de Hierro Majadahonda University Hospital
Madrid, Spain, 28222
Actively Recruiting
52
Clínico Universitario de Valencia
Valencia, Spain, 46000
Actively Recruiting
53
Hospital General Valencia
Valencia, Spain, 46000
Actively Recruiting
Research Team
A
Annemarie Forrest
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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