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

Study acronym: INTeGRATE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Sep 1, 2026 to Oct 2, 2026
    • Study sites: 15 to 17
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: details revised at 3 of 20 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Start date: Apr 1, 2026 to Sep 1, 2026
    • Trial sites expanded: 7 → 15 locations
    • Eligibility criteria expanded, about 55 words
    • Study description expanded, about 32 words
    v6
  3. Primary endpoint(s) modifiedv5 Show 5 more changesShow less
    • Enrollment increased: 60 → 250 participants
    • Study sites: 5 to 7
    • Eligibility criteria shortened, about 86 words
    • Secondary endpoints expanded, about 106 words
    • Study description shortened, about 11 words
  4. Primary completion date: Dec 1, 2027 to Dec 1, 2028
    • Start date: Dec 1, 2025 to Apr 1, 2026
    • Study completion date: Jun 1, 2028 to Jun 1, 2029
    v4
  5. Site contacts updated at 2 of 5 sitesv3
  6. Study sites: 0 to 5
    • Study title shortened, about 1 word
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Abiomed Inc.
13 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT06965504
Lead Sponsor Abiomed Inc.
Collaborators: Johnson & Johnson
Conditions
(from sponsor)		 Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure
Related terms Cardiovascular Diseases, Heart Diseases, Heart Failure, Heart Failure, Systolic, Shock, Cardiogenic
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov