Acute Decompensated Heart FailureFASTR-EUNCT06362668
EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)
A study testing Reprieve Decongestion Management System and Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) in people with Acute Decompensated Heart Failure, run by Reprieve Cardiovascular, Inc at 2 sites in 2 countries.
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 (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 May 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)
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 is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Reprieve Decongestion Management System, Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)
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.
Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)Drug
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 [Diuretic Strategies in Patients with Acute Heart Failure Trail (DOSE), Acetazolamide in Decompensated Heart Failure with Volume Overload Trial (ADVOR), and Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure Trial (CLOROTIC)] for patients randomized to control arm of the trial. Receives: Drug: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sodium loss (in mmol of sodium) per 24 hours
Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).
Measured: End of treatment, an average of 72 hours
Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.
Primary safety endpoint is positive if any of the following occurs in an individual participant:
- Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) [≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)]
- Severe electrolyte abnormality defined as serum potassium <3.0 milliequivalent/liter (mEq/L), magnesium <1.3 mEq/L, or sodium <135 mEq
- Symptomatic hypotension (systolic pressure <80mmHg) or hypertensive (systolic pressure >200 mmHg and/or diastolic pressure >120 mmHg) emergency.
Measured: Through study completion, an average of 90 days
Secondary outcomes (4)
Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours
Difference between volume of urine output and fluid input during primary treatment normalized to 24 hours.
Measured: End of treatment, an average of 72 hours
Weight loss per 24 hours at end of randomized therapy
Total time on loop diuretics during primary treatment
Measured: End of treatment, an average of 72 hours
Time on IV loop diuretic
Total time on loop diuretics from initiation of randomized therapy to last dose of IV loop diuretic administered for ADHF
Measured: End of treatment, an average of 72 hours
Number of participants with ≥ 0.3 mg/dL increase in serum creatinine
In hospital worsening renal function defined as ≥ 0.3 mg/dL increase in serum creatinine during randomized therapy.
Measured: End of treatment, an average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start17 May 2024
- Primary completion1 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reprieve Cardiovascular, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362668
- Sponsor's protocol ID
- RCV-0006-EU
- Acronym
- FASTR-EU
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Cox 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)
- ClinicalTrials.gov ID
- NCT06362668
- Acronym / sponsor ID
- FASTR-EU / RCV-0006-EU
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Reprieve Cardiovascular, IncIndustry (pharma, biotech, devices)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 12 Apr 2024 (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 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 is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.
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: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials [Diuretic Strategies in Patients with Acute Heart Failure Trail (DOSE), Acetazolamide in Decompensated Heart Failure with Volume Overload Trial (ADVOR), and Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure Trial (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 |
| Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC). | Drug | Optimal Diuretic Therapy |
Primary outcome
Total sodium loss (in mmol of sodium) per 24 hours
Time frame: End of treatment, an average of 72 hours
Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).
Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.
Time frame: Through study completion, an average of 90 days
Primary safety endpoint is positive if any of the following occurs in an individual participant: 1. Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) [≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)] 2. Severe electrolyte abnormality defined as serum potassium <3.0 milliequivalent/liter (mEq/L), magnesium <1.3 mEq/L, or sodium <135 mEq 3. Symptomatic hypotension (systolic pressure <80mmHg) or hypertensive (systolic pressure >200 mmHg and/or diastolic pressure >120 mmHg) emergency.
4 secondary outcomes
Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours
Time frame: End of treatment, an average of 72 hours
Weight loss per 24 hours at end of randomized therapy
Time frame: End of treatment, an average of 72 hours
Time on IV loop diuretic
Time frame: End of treatment, an average of 72 hours
Number of participants with ≥ 0.3 mg/dL increase in serum creatinine
Time frame: End of treatment, an average of 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: 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 (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) in people with Acute Decompensated Heart Failure, run by Reprieve Cardiovascular, Inc at 2 sites in 2 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 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 sodium loss (in mmol of sodium) per 24 hours (time frame: End of treatment, an average of 72 hours). 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 NCT06362668, which also lists 1 linked publication.
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 10 Mar 2025.