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

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Device: Reprieve Decongestion Management System; Drug: Diuretic

• Registration Number: NCT05174312
• Lead Sponsor: Reprieve Cardiovascular, Inc

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 can more efficiently decongest ADHF patients in comparison to Control Therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-30
• Study Start: 2022-07-11
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reprieve Decongestion Management System	Reprieve Decongestion Management System	Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
Optimal Diuretic Therapy	Diuretic	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.

Primary Outcome Measures

Name	Time	Method
Total urine sodium output	24 hours post-treatment initiation	Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.	Through study completion, an average of 90 days	Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI \[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\], severe electrolyte abnormality (serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq), symptomatic hypotension or hypertensive emergency.

Secondary Outcome Measures

Name	Time	Method
Net fluid loss	End of treatment, an average of 72 hours	Difference in the amount of net fluid removed during primary treatment
Time on loop diuretics	End of treatment, an average of 72 hours	Total time on loop diuretics during primary treatment

Trial Locations

Locations (7)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Cone Health; 🇺🇸 Greensboro, North Carolina, 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