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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reprieve Cardiovascular, Inc
• Treatments: Diuretics

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 with a total daily dose of 80 mg to 400 mg furosemide equivalents for a minimum of 30 says prior to admission.

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. Inability to follow instructions or comply with follow-up procedures.

6. 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.

7. Severe electrolyte abnormalities.

8. Presence of active COVID-19 infection.

9. Enrollment in another interventional trial during the index hospitalization.

10. Inability of the patient to stand and obtain daily standing weights.

11. Inability to return for follow-up study visits.

12. Life expectancy less than 3 months.

13. Women who are pregnant or intend to become pregnant.