Clinical Trial

INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

Study acronym: INTeGRATE
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-04-24
notable Enrollment increased: 60 -> 250 participants 2026-04-24
Trial Details
NCT Number NCT06965504
Lead Sponsor Abiomed Inc.
Collaborators: Johnson & Johnson
Conditions Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure
Enrollment 250 participants
Start Date 2026-04-01
Primary Completion 2028-12-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-23