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Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

RECRUITINGN/ASponsored by Nuwellis, Inc.
Actively Recruiting
PhaseN/A
SponsorNuwellis, Inc.
Started2022-06-28
Est. completion2026-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations17 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Fluid OverloadHeart DiseaseHeart FailureHeart Failure (for Example, Fluid Overload)

Locations17 sites

Banner Health
Tucson, Arizona, 85721
Dalise Dai312-237-5891daliseshatz@arizona.edu
MemorialCare, Long Beach Medical Center
Long Beach, California, 90806
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego, California, 92123
Emma Burkhalter, RN, MSN858-244-6889eburkhalter@sdcardiac.com
University of California San Francisco
San Francisco, California, 94143
BayCare Medical Group, Morton Plant
Clearwater, Florida, 33756

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