Clinical trial NCT06362668: EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)
Official title: EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Lead sponsor: Reprieve Cardiovascular, Inc
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
2. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
3. Prior use of loop diuretics within 30 says prior to admission.
4. ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter.
2. Hemodynamic instability.
3. Dyspnea due primarily to non-cardiac causes.
4. Acute infection with evidence of systemic involvement.
5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
6. 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.
7. Inability to follow instructions or comply with follow-up procedures.
8. 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.
9. Severe electrolyte abnormalities.
10. Presence of active coronavirus disease 2019 (COVID-19) infection.
11. Enrollment in another interventional trial during the index hospitalization.
12. Inability to return for follow-up study visits.
13. Life expectancy less than 3 months.
14. Women who are pregnant or intend to become pregnant.

Primary outcomes:
measure: Total sodium loss (in mmol of sodium) per 24 hours
timeFrame: End of treatment, an average of 72 hours
measure: Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.
timeFrame: Through study completion, an average of 90 days
Secondary outcomes:
measure: Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours
timeFrame: End of treatment, an average of 72 hours
measure: Weight loss per 24 hours at end of randomized therapy
timeFrame: End of treatment, an average of 72 hours
measure: Time on IV loop diuretic
timeFrame: End of treatment, an average of 72 hours
measure: Number of participants with ≥ 0.3 mg/dL increase in serum creatinine
timeFrame: End of treatment, an average of 72 hours
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
References: