NCT07141355Recruiting
Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
Microcirculatory Effects of Empagliflozin in Patients With Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 12 Dec 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Heart failure
- NCT number
- NCT07141355
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 12 Dec 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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:
Other
- Pregnant woman, woman in labor, or breastfeeding mother
- Minor person (not emancipated)
- Adult person subject to a legal protection measure (guardianship, curatorship, legal safeguard)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.