Ultrafiltration Versus IV Diuretics in Worsening Heart Failure (NCT05318105) | Clinical Trial Compass
TerminatedNot Applicable
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Stopped: The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.
United States167 participantsStarted 2022-06-28
Plain-language summary
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.
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:
* 18 years or older
* Man, or non-pregnant woman
* Admitted to the hospital with a diagnosis of acute decompensated heart failure
* On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission
* Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)
* Provide written informed consent
Exclusion Criteria:
* New diagnosis of heart failure
* Acute coronary syndromes
* Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
* Contraindications to systemic anticoagulation
* Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days
* Sepsis or ongoing systemic infection
* Active myocarditis
* Constrictive pericarditis or restrictive cardiomyopathy
* Severe aortic stenosis
* Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.