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Completed

NCT Number: NCT06362668

EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (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.

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Key information

Conditions

Acute Decompensated Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Reprieve Decongestion Management System

Device

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).

Primary outcomes

  1. 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).

  2. 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:

    • 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.

Secondary outcomes

  1. 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

    Difference between volume of urine output and fluid input during primary treatment normalized to 24 hours.

  2. Weight loss per 24 hours at end of randomized therapy

    Time frame: End of treatment, an average of 72 hours

    Total time on loop diuretics during primary treatment

  3. Time on IV loop diuretic

    Time frame: End of treatment, an average of 72 hours

    Total time on loop diuretics from initiation of randomized therapy to last dose of IV loop diuretic administered for ADHF

  4. Number of participants with ≥ 0.3 mg/dL increase in serum creatinine

    Time frame: End of treatment, an average of 72 hours

    In hospital worsening renal function defined as ≥ 0.3 mg/dL increase in serum creatinine during randomized therapy.

Sponsors and collaborators

Lead sponsor

Reprieve Cardiovascular, Inc

Industry

Registry information

Official study title

EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)

Acronym: FASTR-EU

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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