Tests the Reprieve System for fluid removal in acute decompensated heart failure
Compares the Reprieve System with standard diuretic drug care for fluid removal in heart failure.
Key facts
- Who runs it
- Reprieve Cardiovascular, Inc
- Where
- Giessen, Hanover, and Heidelberg, GermanySee the 3 sitesAlso in 4 other countries, 47 sites
- Trial code
- Registry title
- Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 28 Jul 2025
- Expected to end
- Dec 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Reprieve System
- furosemide infusion
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in hospital with acute decompensated heart failure and extra fluid, who take a daily loop diuretic and may respond poorly to diuretics.
- Age
- 22 years or older
- Sex
- All sexes
- Disease stage
- Heart failure with fluid build-up, expected to stay in hospital more than 24 hours. At least 10 lb (4.5 kg) above dry weight as estimated by the health care provider.
- Earlier treatment
- Must currently have an outpatient prescription for a daily loop diuretic.
- Biomarker or test result
- At least one sign of possible diuretic resistance: low blood chloride, urine output under 1 L in the 6 hours after IV loop diuretic of at least 40 mg furosemide equivalent, or spot urine sodium under 100 mmol/L 1-2 hours after that dose.
Main reasons for not taking part
- Unstable blood pressure or heart rhythm, or recent IV vasopressors or inotropes
- Kidney function eGFR under 25 ml/min/1.73m2 or on kidney replacement therapy
- Heart attack, bypass surgery or stroke in the last 30 days
- Severe electrolyte problems or acute infection affecting the whole body
- Pregnant or breastfeeding, or life expectancy under 6 months
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
- Currently enrolled in an interventional trial (observational studies are permitted)
- Life expectancy less than 6 months
- Women who are pregnant or breastfeeding
Where in Germany
Also in 4 other countries, 47 sites
- Universitätsklinikum Gießen (UKGM)Giessen, GermanyContact: Annemarie ForrestTaking people
- Hannover University HospitalHanover, GermanyContact: Annemarie ForrestTaking people
- University Hospital HeidelbergHeidelberg, GermanyContact: Annemarie ForrestTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Reprieve SystemTreatment being tested
Participants randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
- Optimal Diuretic Therapy (ODT)Existing treatment, for comparison
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
Treatment: furosemide infusion
- RegistryNo study treatment, for comparison
Participants will be treated per local site usual care.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
- Plain-language title
- Tests the Reprieve System for fluid removal in acute decompensated heart failureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 October 2026