The trial is taking place at:
A

Ascension | Ascension Texas Cardiovascular

Veeva-enabled site

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

R

Reprieve Cardiovascular

Status

Enrolling

Conditions

Acute Decompensated Heart Failure

Treatments

Device: Reprieve Decongestion Management System
Drug: Diuretic

Study type

Interventional

Funder types

Industry

Identifiers

NCT05174312
RCV-0006

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

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.
  • 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 COVID-19 infection.
  • Enrollment in another interventional trial during the index hospitalization.
  • Inability of the patient to stand and obtain daily standing weights.
  • Inability to return for follow-up study visits.
  • Life expectancy less than 3 months.
  • Women who are pregnant or intend to become pregnant.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Reprieve Decongestion Management System
Experimental group
Description:
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
Treatment:
Device: Reprieve Decongestion Management System
Optimal Diuretic Therapy
Active Comparator group
Description:
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.
Treatment:
Drug: Diuretic

Trial contacts and locations

6

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Central trial contact

Arslan Malik

Data sourced from clinicaltrials.gov

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