NCT05064202

Unloading in Heart Failure Cardiogenic Shock

Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

Detailed description

To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	Impella 5.5	temporary Mechanical Circulatory Support (tMCS)
DRUG	Inotropes	Enoximone, Dobutamine, Dopamine, Milrinone

Timeline

• Start date: 2023-10-01
• Primary completion: 2027-10-01
• Completion: 2028-07-01
• First posted: 2021-10-01
• Last updated: 2023-08-01

Locations

5 sites across 1 country: Netherlands