Acute Decompensated Heart FailureFASTR-IINCT06898515
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
A study testing Reprieve System and furosemide infusion in people with Acute Decompensated Heart Failure, run by Reprieve Cardiovascular, Inc at 50 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Reprieve System and furosemide infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 50 sitesin 5 countries
- Study dates
- 28 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
50 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 5 countries
United States35 sites, 35 recruiting
- Recruiting
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan, 48197
- Recruiting
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
- Recruiting
Wellstar Hospital
Atlanta, Georgia, 30312
- Recruiting
Piedmont Augusta Hospital
Augusta, Georgia, 30901
- Recruiting
Lindner Center at Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Ohio State University Hospital
Columbus, Ohio, 43210
- Recruiting
Baylor Scott and White
Dallas, Texas, 75246
- Recruiting
Duke University
Durham, North Carolina, 27710
- Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
- Recruiting
University of Florida
Gainesville, Florida, 32610
- Recruiting
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
- Recruiting
Corewell Health Butterworth Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
- Recruiting
Baylor College of Medicine Ben Taub Hospital
Houston, Texas, 77030
- Recruiting
Houston Methodist
Houston, Texas, 77030
- Recruiting
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030
- Recruiting
University of California Irvine
Irvine, California, 92697
- Recruiting
University of Mississippi
Jackson, Mississippi, 39216
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103
- Recruiting
Memorial Care Long Beach
Long Beach, California, 90806
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
- Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
- Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37235
- Not yet recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
- Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
VCU Medical Center
Richmond, Virginia, 23219
- Recruiting
Corewell William Beaumont University Hospital
Royal Oak, Michigan, 48073
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
- Recruiting
St. Louis VA
St Louis, Missouri, 63130
- Recruiting
Washington University
St Louis, Missouri, 63130
- Recruiting
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Spain6 sites, 6 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
- Recruiting
Hospital de Bellvitge
Barcelona, 08907
- Recruiting
Hospital Ramon y Cajal
Madrid, 28000
- Recruiting
Puerta de Hierro Majadahonda University Hospital
Madrid, 28222
- Recruiting
Clínico Universitario de Valencia
Valencia, 46000
- Recruiting
Hospital General Valencia
Valencia, 46000
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Gießen (UKGM)
Giessen, 35392
- Recruiting
Hannover University Hospital
Hanover, 30625
- Recruiting
University Hospital Heidelberg
Heidelberg
Italy3 sites, 3 recruiting
- Recruiting
Universitaria delle Marche
Ancona, 60121
- Recruiting
ASST Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
- Recruiting
ASST Niguarda Great Metropolitan Hospital
Milan, 20162
Poland3 sites, 3 recruiting
- Recruiting
Medical University of Białystok
Bialystok, 15-089
- Recruiting
Medical University of Lodz
Lodz, 70445
- Recruiting
University Hospital Wroclaw
Wroclaw, 45573
About this study
Official title: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
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.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Reprieve System, furosemide infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reprieve SystemDevice
The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
furosemide infusionDrug
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
| Study group | Role | What they receive |
|---|---|---|
| Reprieve System | Experimental | Participants randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment. Receives: Device: Reprieve System |
| Optimal Diuretic Therapy (ODT) | Active comparator | Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy Receives: Drug: furosemide infusion |
| Registry | No intervention | Participants will be treated per local site usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite/win-ratio
- Freedom from 30-day CV mortality
- Freedom from HF Rehospitalization 30 days post-discharge
- Greater net sodium loss per 24 hours during treatment
Measured: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)
KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition
Measured: initiation of randomized therapy through 72 hours following completion of randomized therapy
Secondary outcomes (11)
Net sodium loss
Measured: per 24 hours at end of randomized therapy
Time to discharge readiness
Time from initiation of randomized therapy to when the participant becomes medically ready for discharge from a decompensated heart failure treatment standpoint
Measured: through hospital discharge, an average of 5 days
Time on IV diuretic therapy
Measured: randomization through hospital discharge, assessed up to 30 days
Net fluid loss
Fluid input subtracted from total urine output
Measured: per 24 hours at end of randomized therapy
Weight loss
Measured: per 24 hours at end of randomized therapy
CV mortality and cumulative HF rehospitalizations
Both types of events will be combined in a total "event rate" compared between groups
Measured: 90 days after hospital discharge
Length of stay
Time from initiation of randomized therapy to hospital discharge
Measured: through hospital discharge, an average of 5 days
Hypotension defined as systolic blood pressure < 80 mmHg documented with two readings at least 30 minutes apart with symptoms (e.g., chest pain, dizziness) or <80 mmHg requiring an intervention including IV fluids or vasopressors.
Measured: initiation of randomized therapy up to 12 hours after stopping randomized therapy
Severe electrolyte abnormality
serum potassium <3.0 mEq/L with ≥ 0.5 mEq/L decrease from initiation of randomized therapy, magnesium <1.3 mEq/L with ≥0.5 mEq/L decrease from initiation of randomized therapy, or sodium <125 mEq/L with ≥ 5.0 mEq/L decrease from initiation of randomized therapy
Measured: initiation of randomized therapy up to 72 hours after stopping randomized therapy
Worsening heart failure requiring a higher level of HF therapy
Measured: initiation of randomized therapy up to 72 hours after stopping randomized therapy
Tinnitus or hearing loss lasting more than 30 minutes
Measured: initiation of randomized therapy up to 12 hours after stopping randomized therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start28 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reprieve Cardiovascular, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javed Butler, MD, MPH, MBA, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898515
- Sponsor's protocol ID
- IDE-G210258-CLN0002
- Acronym
- FASTR-II
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
- ClinicalTrials.gov ID
- NCT06898515
- Acronym / sponsor ID
- FASTR-II / IDE-G210258-CLN0002
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Reprieve Cardiovascular, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reprieve System | Experimental | Device: Reprieve SystemParticipants 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) | Active comparator | Drug: furosemide infusionParticipants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy |
| Registry | No intervention | –Participants will be treated per local site usual care. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reprieve SystemThe Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure. | Device | Reprieve System |
| furosemide infusionParticipants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy | Drug | Optimal Diuretic Therapy (ODT) |
Primary outcome
Hierarchical composite/win-ratio
Time frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment
Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)
Time frame: initiation of randomized therapy through 72 hours following completion of randomized therapy
KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition
11 secondary outcomes
Net sodium loss
Time frame: per 24 hours at end of randomized therapy
Time to discharge readiness
Time frame: through hospital discharge, an average of 5 days
Time on IV diuretic therapy
Time frame: randomization through hospital discharge, assessed up to 30 days
Net fluid loss
Time frame: per 24 hours at end of randomized therapy
Weight loss
Time frame: per 24 hours at end of randomized therapy
CV mortality and cumulative HF rehospitalizations
Time frame: 90 days after hospital discharge
Length of stay
Time frame: through hospital discharge, an average of 5 days
Hypotension defined as systolic blood pressure < 80 mmHg documented with two readings at least 30 minutes apart with symptoms (e.g., chest pain, dizziness) or <80 mmHg requiring an intervention including IV fluids or vasopressors.
Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy
Severe electrolyte abnormality
Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
Worsening heart failure requiring a higher level of HF therapy
Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
Tinnitus or hearing loss lasting more than 30 minutes
Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javed Butler, MD, MPH, MBA principal investigator
Baylor Scott and White Health
50 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reprieve System and furosemide infusion in people with Acute Decompensated Heart Failure, run by Reprieve Cardiovascular, Inc at 50 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Spain, Germany, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemarie Forrest (617-848-0400, aforrest@reprievecardio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite/win-ratio (time frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.