Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT05174312

Recruitment Status:

Recruiting

Sponsor:

Reprieve Cardiovascular, Inc

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There are 6 Locations for this study

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MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Duke University Hospital
Durham North Carolina, 27710, United States
Cone Health
Greensboro North Carolina, 27401, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Prisma Health
Columbia South Carolina, 29203, United States
Ascension Texas Cardiovascular
Austin Texas, 78705, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT05174312

Recruitment Status:

Recruiting

Sponsor:


Reprieve Cardiovascular, Inc

How clear is this clinincal trial information?

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