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Diuretic

Reprieve Decongestion Management System for Heart Failure (FASTR Trial)

N/A
Recruiting
Research Sponsored by Reprieve Cardiovascular, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign
Prior use of loop diuretics within 30 days prior to admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 90 days
Awards & highlights

FASTR Trial Summary

This trialwill compare two treatments for acute heart failure to see which is more effective. #health #heartfailure

Who is the study for?
This trial is for hospitalized patients with acute decompensated heart failure who have symptoms and signs of the condition, are significantly above their dry weight, and have been on loop diuretics. It's not suitable for those with unstable vital signs, non-heart-related breathing issues, severe infections or electrolyte problems, active COVID-19, other serious health conditions including substance abuse or mental disorders that affect study compliance.Check my eligibility
What is being tested?
The study compares a new therapy using the Reprieve Decongestion Management System to standard Optimal Diuretic Therapy in treating acute decompensated heart failure. The goal is to see if the Reprieve system can better remove excess fluid from patients compared to conventional diuretic treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, treatments like these may cause changes in blood pressure, kidney function alterations, electrolyte imbalances (like low potassium), discomfort at catheter sites and potential allergic reactions.

FASTR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am hospitalized with heart failure, having both symptoms and signs.
Select...
I have used water pills within the last 30 days.

FASTR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.
Total urine sodium output
Secondary outcome measures
Net fluid loss
Time on loop diuretics

Side effects data

From 2019 Phase 2 trial • 130 Patients • NCT03136198
8%
NSTEMI type 2
6%
Acute Kidney Injury
3%
Respiratory failure
2%
Mural thrombus
2%
Nonsustained ventricular tachycardia
2%
Bradycardia
2%
Hypotension
2%
NSTEMI
2%
Iron deficiency anemia
2%
MGUS, new diagnosis
2%
Hyperkalemia
2%
Urinary retention
2%
Proteinuria
2%
Pulmonary embolism
2%
Mitral Regurgitation, severe
2%
Mitral valve disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
LUS-guided Strategy-of-care

FASTR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reprieve Decongestion Management SystemExperimental Treatment1 Intervention
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
Group II: Optimal Diuretic TherapyActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Reprieve Cardiovascular, IncLead Sponsor
3 Previous Clinical Trials
81 Total Patients Enrolled
3 Trials studying Heart Failure
81 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of this experiment's volunteer pool?

"To successfully execute the trial, Reprieve Cardiovascular, Inc. seeks to enroll 100 participants that meet all requirements for participation. The medications will be administered in Burlington (Vermont) at University of Vermont and Cone Health in Greensboro (North carolina)."

Answered by AI

Is this experiment taking place in multiple areas of the U.S.?

"Currently, 4 sites are enrolling patients with locations in Burlington, Greensboro and Norfolk as well as additional centres. To reduce time spent travelling to the trial site, it is encouraged that individuals select the closest location available."

Answered by AI

Are there currently slots available for this research endeavor?

"Clinicaltrials.gov states that this medical trial is still looking for participants, having originally been posted on July 11th 2022 and last edited November 2nd of the same year."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
2022. "Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174312.
~5 spots leftby Jun 2024
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