Reprieve Decongestion Management System for Acute Decompensated Heart Failure (ADHF)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Decompensated Heart Failure (ADHF)+1 More
Reprieve Decongestion Management System - Device
Eligibility
18+
All Sexes
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Study 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.

Eligible Conditions
  • Acute Decompensated Heart Failure (ADHF)

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Through study completion, an average of 90 days

Hour 72
Change in weight
Efficient decongestion
Time on loop diuretics
Day 90
Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.

Trial Safety

Side Effects for

LUS-guided Strategy-of-care
6%Acute Kidney Injury
2%Supratherapeutic digoxin level
2%Constipation
2%NSTEMI
2%Cough
2%Hyponatremia
2%Gross hematuria
2%Hypotension
2%Nonsustained ventricular tachycardia
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03136198) in the LUS-guided Strategy-of-care ARM group. Side effects include: Acute Kidney Injury with 6%, Supratherapeutic digoxin level with 2%, Constipation with 2%, NSTEMI with 2%, Cough with 2%.

Trial Design

2 Treatment Groups

Optimal Diuretic Therapy
1 of 2
Reprieve Decongestion Management System
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Reprieve Decongestion Management System · No Placebo Group · N/A

Reprieve Decongestion Management System
Device
Experimental Group · 1 Intervention: Reprieve Decongestion Management System · Intervention Types: Device
Optimal Diuretic Therapy
Drug
ActiveComparator Group · 1 Intervention: Diuretic · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 90 days

Who is running the clinical trial?

Reprieve Cardiovascular, IncLead Sponsor
1 Previous Clinical Trials
31 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.