Mechanical Left Ventricular Unloading in Acute Decompensated Heart Failure

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to evaluate whether initial temporary circulatory support through the Impella CP® system in patients with acute decompensated heart failure (ADHF) and in-hospital worsening heart failure (WHF) in whom inotropes are deemed necessary, has the potential to reduce the heart failure related-clinical events compared to the current standard of care.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborator: Abiomed Inc.

Criteria

Inclusion Criteria:

1. Evidence of HFrEF according to ESC HF guidelines, preferably LVEF ≤ 35%

2. Evidence of in-hospital worsening heart failure requiring escalation of inotropic therapy according to the treating heart failure cardiologist based on at least 3 / 4 predefined hemodynamic and clinical criteria

3. No previous episodes of inotropic treatment during current admission or within the last month

4. Age: 18 - 80 years

Exclusion Criteria:

1. Contraindications for Impella CP

2. Severe concomitant RV failure

3. Grade IV mitral regurgitation eligible for surgical treatment

4. Contraindications for inotropic usage

5. Dialysis for end-stage renal failure

6. Acute coronary syndrome

7. History of CVA or TIA within previous 90 days

8. History of acute myocardial infarction within previous 30 days

9. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions

10. Inflammatory

11. Active systemic infections

12. Acute myocarditis

13. Active on transplant waiting list