NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
| NCT ID | NCT05677100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Procyrion |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2027-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.
Eligibility Criteria
Inclusion Criteria (Randomized Study): * Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF); * Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on 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, patient must have: Urine Output \<1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period. * Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.; * Age \>21 years and able to provide written informed consent; * Negative pregnan
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.