Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
Recruiting · NCT07141355 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Strasbourg, France
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 with acute heart failure led to a composite benefit in mortality, rehospitalization, and quality of life. Growing evidence suggests that cardiogenic shock isn't just a problem of systemic macrocirculation (blood pressure, cardiac output). It also involves significant abnormalities in the systemic microcirculation. In fact, these microcirculatory parameters have proven to be better predictors of patient outcomes than traditional macrocirculatory measures. Given its known vasculo-protective effects on the endothelium, empagliflozin may have a beneficial impact on the microcirculation, potentially explaining its positive effects in cardiogenic shock. This study will explore this hypothesis by analyzing the microcirculation in real-time using the CytoCam-IDF imaging videomicroscope and its MicroTools software. The goal is to gain a deeper understanding of how empagliflozin affects the microcirculation during cardiogenic shock.
Who can take part
Inclusion criteria
- 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 criteria
- • 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)
Where it is running
1 location listed.
- Hôpitaux Universitaires de Strasbourg - Strasbourg, France