NCT06965504

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

Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate if Impella 5.5® support in heart failure reduced ejection fraction (HFrEF) patients presenting with decompensated heart failure (HF) and cardiogenic shock will facilitate the initiation and optimization of guideline directed medical therapy (GDMT) during the hospital stay and post-discharge.

Detailed description

This is a prospective, single arm, multi-center, post-market, on-label study. Patients presenting with HFrEF who are not on adequate GDMT and who are presenting with heart failure cardiogenic shock will be evaluated for inclusion. The study objectives are to evaluate the impact of Impella 5.5 support on GDMT up-titration during support, at discharge, and at 90-days post-discharge and to evaluate the feasibility of Impella 5.5 combined with optimal GDMT to improve heart recovery in patients with decompensated heart failure. Outcomes will be measured up to one-year post-hospital discharge.

Conditions

• Heart Failure
• Cardiogenic Shock
• Reduced Ejection Fraction Heart Failure

Interventions

Type	Name	Description
DEVICE	Impella 5.5 SmartAssist	The intervention is Impella 5.5 with SmartAssist® support combined with heart failure guideline directed medical therapy (GDMT).

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2025-05-11
• Last updated: 2026-03-05

Locations

5 sites across 1 country: United States