Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion… (NCT05174312) | Clinical Trial Compass
CompletedNot Applicable
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
United States100 participantsStarted 2022-07-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. ≥ 18 years of age able to provide informed consent and comply with study procedures.
Exclusion criteria
. Inability to place Foley catheter or IV catheter.
. Hemodynamic instability.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a device called the Reprieve Decongestion Management System to guide fluid removal in acute decompensated heart failure — has my care team looked at this system, and do you think a guided approach like this could be relevant to how my fluid management is handled?
2The trial measured total urine sodium output as a key outcome — can you explain what urine sodium tells you about how well my body is responding to diuretic treatment, and is that something you already track in my case?
3The study also tracked serious risks like acute kidney injury, dangerous electrolyte imbalances, and blood pressure emergencies during decongestion — how do you currently monitor me for those same complications when removing fluid, and what would prompt you to change course?
4Since this trial is now completed, have any results been published yet, and if so, do the findings change how you might approach my treatment compared to standard diuretic therapy alone?
5Given that this was listed as Phase NA — meaning it wasn't a standard drug efficacy trial but more of a device or management study — how much weight should I give its findings when thinking about my own treatment options right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Urine Sodium Output
Timeframe: 24 hours post-treatment initiation
2
Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.
. Acute infection with evidence of systemic involvement.
. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
. 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.
. 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.