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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Device: Reprieve Decongestion Management System
    The Reprieve Decongestion Management System, or Reprieve DMS, is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
Active Comparator
Optimal Diuretic Therapy 		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.
  • Drug: Diuretic
    Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

More Details

Status
Active, not recruiting
Sponsor
Reprieve Cardiovascular, Inc

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.