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

Completed · Not applicable

Conditions studied: Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT05174312

Run by

Reprieve Cardiovascular, Inc

People needed

100

Starts

2022-07-11

Expected to finish

2025-01-10

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Eastern Shore Research Institute — Fairhope, Alabama, United States
• University of California Irvine — Irvine, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Trinity Health Ann Arbor Hospital — Ypsilanti, Michigan, United States
• St. Louis VA — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Duke University Hospital — Durham, North Carolina, United States
• Cone Health — Greensboro, North Carolina, United States
• Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• The Lindner Research Center at Christ Hospital — Cincinnati, Ohio, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Prisma Health — Columbia, South Carolina, United States
• Ascension Texas Cardiovascular — Austin, Texas, United States
• Baylor Scott & White — Dallas, Texas, United States
• University of Vermont Medical Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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