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

RecruitingPhase 3

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

Who can join

Ages 22 and older · All sexes

Full 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.

About the 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.

What is being tested

Sponsor: Reprieve Cardiovascular, Inc · Participants: 400 · Started: Jul 14, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06898515

Locations in the U.S.

CaliforniaUniversity of California Irvine, Irvine
Scripps Memorial Hospital, La Jolla (Not yet recruiting)
UC Davis Medical Center, Sacramento
FloridaUniversity of Florida, Gainesville
GeorgiaPiedmont Atlanta Hospital, Atlanta
Piedmont Augusta Hospital, Augusta
Northeast Georgia Medical Center, Gainesville
IllinoisAdvocate Christ Medical Center, Oak Lawn (Not yet recruiting)
KansasUniversity of Kansas Medical Center, Kansas City
KentuckyUniversity of Louisville Hospital, Louisville (Not yet recruiting)
MichiganTrinity Health Ann Arbor Hospital, Ann Arbor
Corewell Health Butterworth Hospital, Grand Rapids
Corewell William Beaumont University Hospital, Royal Oak
MinnesotaMinneapolis Heart Institute, Minneapolis
MississippiUniversity of Mississippi, Jackson
MissouriHarry S. Truman Veteran's Memorial Hospital, Columbia (Not yet recruiting)
St. Louis VA, St Louis
Washington University, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New YorkStony Brook University Hospital, Stony Brook
North CarolinaDuke University, Durham (Not yet recruiting)
Moses H. Cone Memorial Hospital, Greensboro (Not yet recruiting)
Atrium Health Wake Forest Baptist Medical Center, Winston-Salem
OhioLindner Center at Christ Hospital, Cincinnati
University of Cincinnati, Cincinnati
UH Cleveland Medical Center, Cleveland
Ohio State University Hospital, Columbus
OklahomaOklahoma Heart Hospital, Oklahoma City
PennsylvaniaUniversity of Pennsylvania, Philadelphia
South CarolinaPrisma Health Greenville Memorial Hospital, Greenville
TexasBaylor Scott and White, Dallas
Baylor College of Medicine Ben Taub Hospital, Houston
Memorial Hermann-Texas Medical Center, Houston
VirginiaInova Fairfax Medical Campus, Falls Church
VCU Medical Center, Richmond
WashingtonUW Harborview, Seattle
WisconsinAurora St. Luke's Medical Center, Milwaukee (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.