Acute Decompensated Heart FailureFASTRNCT05174312
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
A study testing Reprieve Decongestion Management System and Diuretic in people with Acute Decompensated Heart Failure, run by Reprieve Cardiovascular, Inc at 16 sites in United States.
Trial summary
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS 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 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Reprieve Decongestion Management System and Diuretic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 16 sitesUnited States
- Study dates
- 11 Jul 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
- ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
- Prior use of loop diuretics within 30 says prior to admission.
- ≥ 18 years of age able to provide informed consent and comply with study procedures.
Who cannot join
- Inability to place Foley catheter or IV catheter.
- Hemodynamic instability.
- Dyspnea due primarily to non-cardiac causes.
- Acute infection with evidence of systemic involvement.
- Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
- Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
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- Inability to follow instructions or comply with follow-up procedures.
- Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
- Severe electrolyte abnormalities.
- Presence of active coronavirus disease 2019 (COVID-19) infection.
- Enrollment in another interventional trial during the index hospitalization.
- Inability to return for follow-up study visits.
- Life expectancy less than 3 months.
- Women who are pregnant or intend to become pregnant.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Ascension Texas Cardiovascular
Austin, Texas, 78705
University of Vermont Medical Center
Burlington, Vermont, 05401
Medical University of South Carolina
Charleston, South Carolina, 29425
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio, 45219
Prisma Health
Columbia, South Carolina, 29203
Ohio State University Hospital
Columbus, Ohio, 43210
Baylor Scott & White
Dallas, Texas, 75246
Duke University Hospital
Durham, North Carolina, 27710
Eastern Shore Research Institute
Fairhope, Alabama, 36532
Cone Health
Greensboro, North Carolina, 27401
University of California Irvine
Irvine, California, 92697
St. Louis VA
St Louis, Missouri, 63130
Washington University
St Louis, Missouri, 63130
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan, 48197
About this study
Official title: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS 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 DMS can more efficiently decongest ADHF patients in comparison to Control Therapy.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Reprieve Decongestion Management System, Diuretic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reprieve Decongestion Management SystemDevice
The Reprieve Decongestion Management System, or Reprieve DMS, 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.
DiureticDrug
Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).
| Study group | Role | What they receive |
|---|---|---|
| Reprieve Decongestion Management System | Experimental | Subjects 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 Decongestion Management System |
| Optimal Diuretic Therapy | Active comparator | Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial. Receives: Drug: Diuretic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Urine Sodium Output
Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Measured: 24 hours post-treatment initiation
Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.
Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI [≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)], severe electrolyte abnormality (serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq), symptomatic hypotension or hypertensive emergency.
Measured: End of treatment, 0-72 hours.
Secondary outcomes (2)
Net Fluid Loss
Difference in the amount of net fluid removed during primary treatment
Measured: End of treatment, 0-72 hours
Time on IV Loop Diuretics
Time from initiation of IV loop diuretics to discontinuation of IV loop diuretics
Measured: 0 hours (treatment initiation) through hospital discharge, up to 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start11 Jul 2022
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reprieve Cardiovascular, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James E. Udelson, MD, Principal investigator, Division of Cardiology and the CardioVascular Center, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174312
- Sponsor's protocol ID
- RCV-0006
- Acronym
- FASTR
- Status last verified
- May 2026
- First submitted
- 6 Dec 2021
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Udelson JE, Javaheri A, Fudim M, Damman K, Biegus J, Afzal A, Amin AN, Bensimhon D, Bischof JJ, Chung ES, Gottlieb RL, Mahler SA, Moreno JD, Ponikowski P, Rao V, Cox Z, Ivey-Miranda J, Collins S, Testani J. Fluid Management of Acute Heart Failure With the Reprieve System: The Randomized Controlled FASTR Trial. JACC Heart Fail. 2026 Aug;14(8):103062. doi: 10.1016/j.jchf.2026.103062. Epub 2026 May 1.
PubMed 42068320Cox ZL, Damman K, Testani JM. Decongestion in heart failure: medical and device therapies. Nat Rev Cardiol. 2025 Dec;22(12):961-977. doi: 10.1038/s41569-025-01152-z. Epub 2025 Apr 28.
PubMed 40295876
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 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 Decongestion Management System (DMS) - FASTR Trial
- ClinicalTrials.gov ID
- NCT05174312
- Acronym / sponsor ID
- FASTR / RCV-0006
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Reprieve Cardiovascular, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Posted 29 May 2026
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 DMS 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 DMS can more efficiently decongest ADHF patients in comparison to Control Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reprieve Decongestion Management System | Experimental | Device: Reprieve Decongestion Management SystemSubjects 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 | Active comparator | Drug: DiureticSites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
- ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
- Prior use of loop diuretics within 30 says prior to admission.
- ≥ 18 years of age able to provide informed consent and comply with study procedures.
Key exclusion criteria (14 listed)
- Inability to place Foley catheter or IV catheter.
- Hemodynamic instability.
- Dyspnea due primarily to non-cardiac causes.
- Acute infection with evidence of systemic involvement.
- Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
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 Decongestion Management SystemThe Reprieve Decongestion Management System, or Reprieve DMS, 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 Decongestion Management System |
| DiureticBest practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC). | Drug | Optimal Diuretic Therapy |
Primary outcome
Total Urine Sodium Output
Time frame: 24 hours post-treatment initiation
Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.
Time frame: End of treatment, 0-72 hours.
Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI [≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)], severe electrolyte abnormality (serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq), symptomatic hypotension or hypertensive emergency.
2 secondary outcomes
Net Fluid Loss
Time frame: End of treatment, 0-72 hours
Time on IV Loop Diuretics
Time frame: 0 hours (treatment initiation) through hospital discharge, up to 1-2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42068320Udelson JE, Javaheri A, Fudim M, Damman K, Biegus J, Afzal A, Amin AN, Bensimhon D, Bischof JJ, Chung ES, Gottlieb RL, Mahler SA, Moreno JD, Ponikowski P, Rao V, Cox Z, Ivey-Miranda J, Collins S, Testani J. Fluid Management of Acute Heart Failure With the Reprieve System: The Randomized Controlled FASTR Trial. JACC Heart Fail. 2026 Aug;14(8):103062. doi: 10.1016/j.jchf.2026.103062. Epub 2026 May 1.
- Derived from this study: PubMed 40295876Cox ZL, Damman K, Testani JM. Decongestion in heart failure: medical and device therapies. Nat Rev Cardiol. 2025 Dec;22(12):961-977. doi: 10.1038/s41569-025-01152-z. Epub 2025 Apr 28.
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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. This study is not recruiting at the moment.
James E. Udelson, MD principal investigator
Division of Cardiology and the CardioVascular Center, Tufts Medical Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reprieve Decongestion Management System and Diuretic in people with Acute Decompensated Heart Failure, run by Reprieve Cardiovascular, Inc at 16 sites in United States.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Urine Sodium Output (time frame: 24 hours post-treatment initiation). 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?
On the ClinicalTrials.gov record for NCT05174312, which also lists 2 linked publications.
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 23 Jun 2026.