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Fluid removal with the Reprieve System for acute decompensated heart failure

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

Phase 3 Interventional Reprieve Cardiovascular, Inc · NCT06898515

This trial will test whether the Reprieve System removes excess fluid more effectively than standard IV diuretics in adults hospitalized with acute decompensated heart failure who are at risk for diuretic resistance.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages22 Years and up
SexAll
SponsorReprieve Cardiovascular, Inc Industry-sponsored
Locations53 sites (Irvine, California and 52 other locations)
Trial IDNCT06898515 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional trial compares device-guided decongestive therapy using the Reprieve System to optimal diuretic therapy (including IV furosemide) in adults admitted with acute decompensated heart failure. Eligible participants are adults expected to remain hospitalized >24 hours, on a chronic loop diuretic, at least 10 lb above dry weight, and meeting predefined markers of elevated diuretic resistance risk (low urine output after IV diuretic, low spot urine sodium, or hypochloremia). Participants receive either the Reprieve System intervention or standard care with diuretics and are monitored for measures of decongestion, urine output, safety, and clinical outcomes. The study is being conducted at several California medical centers and aims to determine whether the device provides more efficient fluid removal than current diuretic strategies.

Who should consider this trial

Good fit: Ideal candidates are adults (≥22 years) hospitalized with acute decompensated heart failure, more than about 10 lb over dry weight, on outpatient loop diuretics, and showing signs that they may be resistant to standard diuretics (low urine output after IV diuretic, low spot urine sodium, or hypochloremia).

Not a fit: Patients unlikely to benefit include those not at risk for diuretic resistance, those with urologic contraindications to catheter placement, or those who are hemodynamically unstable or expected to have very short admissions.

Why it matters

Potential benefit: If successful, the Reprieve System could help remove excess fluid faster and improve symptoms and possibly shorten hospital stays for patients with ADHF who respond poorly to diuretics.

How similar studies have performed: Earlier-stage and device-assisted decongestion studies have shown some promising signals but definitive large-scale phase 3 evidence for device-based approaches remains limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Irvine, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Decompensated Heart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.