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Microcirculatory Effects of Empagliflozin in Patients With Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 24
Treatments
Active_comparator: Patient in cardiogenic shock under empagliflozin
Subgroup of patients from the EMPASHOCK trial, in which microcirculation parameters will be evaluated at inclusion (before being under empagliflozin treatment) and again after 48 hours.
Sham_comparator: Patient in cardiogenic shock without empagliflozin
Subgroup of patients from the EMPASHOCK trial, without empagliflozin, in which microcirculation parameters will be evaluated at inclusion and again after 48 hours.
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov