INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock… (NCT06965504) | Clinical Trial Compass
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INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
United States250 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 and \< 80 years
✓. Subject has signed the Informed Consent Form. If the subject has been enrolled via an LAR, the subject must provide assent, the assent will be documented.
✓. LVEF ≤ 40%
✓. Subject is presenting with decompensated heart failure and meets at least one (1) of the following cardiogenic shock criteria:
✓. Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure.
✓. Cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia.
✓. Require support with an intra-aortic balloon pump (IABP)
✓. Serum lactate \>2 mmol/L
Exclusion criteria
✕. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:
✕. Drug allergies or hypersensitivities\* to HF GDMT medications, unless alternative can be identified.
✕. Known bilateral renal artery stenosis
✕. Type 1 diabetes
✕. 2o or 3o AV block, unless pacemaker is in place
What they're measuring
1
Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)