Status:
RECRUITING
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Lead Sponsor:
Nuwellis, Inc.
Conditions:
Heart Failure (for Example, Fluid Overload)
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT05318105
Start Date
June 28 2022
End Date
December 31 2026
Last Update
May 15 2025
Active Locations (17)
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1
Banner Health
Tucson, Arizona, United States, 85721
2
MemorialCare, Long Beach Medical Center
Long Beach, California, United States, 90806
3
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego, California, United States, 92123
4
University of California San Francisco
San Francisco, California, United States, 94143