Status:
ACTIVE_NOT_RECRUITING
Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Despite advancements in treatment, the mortality rate for cardiogenic shock (CS) remains high at around 50%. The EMPULSE-HF trial showed that early introduction of empagliflozin in stabilized patients...
Detailed Description
This ancillary pilot study, conducted in an ICU, investigates the real-time microcirculatory effects of empagliflozin in patients with cardiogenic shock (CS). The study aims to determine if the drug i...
Eligibility Criteria
Inclusion
- Patient included in the main EMPASHOCK study
- Patient has signed a consent form for the ancillary study
- Patient is over 18 years old
- Hospitalized in the Intensive Care Unit for cardiogenic shock\*
- Has been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock\*\*
- Patient has the ability to take tablets orally
- Person is affiliated with or a beneficiary of a social security system
Exclusion
- • GFR \< 20 ml/min/1.73m²
- Chronic dialysis
- Patient on SGLT2 inhibitors prior to ICU admission
- Known allergy to SGLT2 inhibitors or any of their excipients (in particular, patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome).
- Patient on lithium
- Patient with type 1 diabetes
- Patient in shock due to another cause or moribund patient (IGS 2 \> 90)
- Cardiogenic shock cases excluded in the EMPASHOCK study: a. Heart transplant recipient or on a transplant list. b. Peripartum, adrenergic, valvular, restrictive, or post-embolic cardiomyopathy. c. Related to cardiotropic drug intoxication. d. Secondary to cardiac arrest where the patient remains comatose before inclusion.
- Woman of childbearing age without effective contraception
- Person referred to in Articles 10, 31, 32, 33, and 34 of EU Regulation 536/2014, specifically:
- Pregnant woman, woman in labor, or breastfeeding mother
- Minor person (not emancipated)
- Adult person subject to a legal protection measure (guardianship, curatorship, legal safeguard)
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07141355
Start Date
July 1 2025
End Date
September 30 2027
Last Update
August 26 2025
Active Locations (1)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000