DRAIN-HF (NCT05677100)

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)

PI: Joggy K. George, MD

Sponsor: Procyrion

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Aortix is a circulatory support device for chronic heart failure (HF) patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.

Eligibility Requirements

1. Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).

2. Urine output for 12 hours prior to enrollment is < 1500 ml following at least 48 hours of the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses as tolerated.

3. Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema or ascites after treatment with IV diuretics per inclusion criterion 2.

4. Age greater than or equal to 21 years and able to provide written informed consent.