Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Reprieve Cardiovascular, Inc · NCT06898515
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 400
- US sites recruiting
- 34
- Study start
- July 28, 2025
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Reprieve System; furosemide infusion
Conditions: Acute Decompensated Heart Failure
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
- ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
- Current outpatient prescription for daily loop diuretic.
- Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
- 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
- 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.
- 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.
- Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minutes within the past 48 hours.
- Severe lung disease with chronic home oxygen requirement >2L/min.
- Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
- 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).
- 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.
- 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.
- 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.
- 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
- Currently enrolled in an interventional trial (observational studies are permitted).
- Life expectancy less than 6 months.
- Women who are pregnant or breastfeeding.
Recruiting US locations
University of California Irvine
Irvine, CA 92697
Memorial Care Long Beach
Long Beach, CA 90806
UC Davis Medical Center
Sacramento, CA 95817
University of Florida
Gainesville, FL 32610
Piedmont Atlanta Hospital
Atlanta, GA 30309
Wellstar Hospital
Atlanta, GA 30312
Piedmont Augusta Hospital
Augusta, GA 30901
Northeast Georgia Medical Center
Gainesville, GA 30501
University of Kansas Medical Center
Kansas City, KS 66103
University of Louisville Hospital
Louisville, KY 40202
Trinity Health Ann Arbor Hospital
Ann Arbor, MI 48197
Corewell Health Butterworth Hospital
Grand Rapids, MI 49503
Corewell William Beaumont University Hospital
Royal Oak, MI 48073
Minneapolis Heart Institute
Minneapolis, MN 55407
University of Mississippi
Jackson, MS 39216
St. Louis VA
St Louis, MO 63130
Washington University
St Louis, MO 63130
Duke University
Durham, NC 27710
Moses H. Cone Memorial Hospital
Greensboro, NC 27401
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, NC 27157
Lindner Center at Christ Hospital
Cincinnati, OH 45219
UH Cleveland Medical Center
Cleveland, OH 44106
Ohio State University Hospital
Columbus, OH 43210
Oklahoma Heart Hospital
Oklahoma City, OK 73120
University of Pennsylvania
Philadelphia, PA 19104
Prisma Health Greenville Memorial Hospital
Greenville, SC 29605
Vanderbilt University Medical Center
Nashville, TN 37235
Baylor Scott and White
Dallas, TX 75246
Baylor College of Medicine Ben Taub Hospital
Houston, TX 77030
Houston Methodist
Houston, TX 77030
Memorial Hermann-Texas Medical Center
Houston, TX 77030
Inova Fairfax Medical Campus
Falls Church, VA 22042
VCU Medical Center
Richmond, VA 23219
Aurora St. Luke's Medical Center
Milwaukee, WI 53215
Study contacts (from the official record)
- Annemarie Forrest · 617-848-0400 · aforrest@reprievecardio.com
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