NCT06362668Completed
EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)
EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)
Source: ClinicalTrials.gov · Last updated 10 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 21 Feb 2024
- Start date
- 17 May 2024
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Reprieve Cardiovascular, Inc
- Diseases
- Heart failure
- NCT number
- NCT06362668
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 17 May 2024 to the primary completion date, 1 Oct 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Dyspnea due primarily to non-cardiac causes.
- Acute infection with evidence of systemic involvement.
- 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.
- Presence of active coronavirus disease 2019 (COVID-19) infection.
Lab values
- Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
Other
- Inability to place Foley catheter or IV catheter.
- Hemodynamic instability.
- Inability to follow instructions or comply with follow-up procedures.
- Severe electrolyte abnormalities.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Wroclaw Medical University Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.