INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery (INTeGRATE) (INTeGRATE)
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- STATUS
- Not Recruiting
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- End date
- Jun 1, 2028
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- participants needed
- 60
-
- sponsor
- Abiomed Inc.
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.
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.
Details
| Condition | Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure |
|---|---|
| Age | 18years - 75years |
| Clinical Study Identifier | NCT06965504 |
| Sponsor | Abiomed Inc. |
| Last Modified on | 18 May 2025 |
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