Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

microcirculation using the video microscopy tool.: The study intervention is the assessment of microcirculation using the video microscopy tool. This study's primary purpose is to perform this specific diagnostic procedure-measuring microcirculatory parameters with the CytoCam-IDF device-at two distinct time points: at inclusion (H0) and again 48 hours later (H48). The administration of empagliflozin (or not), which is pa and 48 hours after initiating empagliflozin treatment, microcirculatory data will be collected using a videomicroscope. A camera, roughly the size of a large pen, is placed under the patient's tongue for a few seconds to acquire images of the sublingual microcirculation. The entire image acquisition process takes less than 5 minutes and is unaffected by whether the patient is intubated. Images are then analyzed in real-time by the MicroTools software, which calculates key microcirculatory parameters. All anonymized images are stored on a dedicated, password-protected computer accessible only to the investigators.

Study 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

Primary outcome measure(s)

• The difference in the evolution of a parameter reflecting the microcirculation between the two groups at 48 hours post-randomization. — Comparison between Day 0 and 48 hours
  To estimate the effect of the early introduction of empagliflozin, in addition to usual care versus usual care alone, at 48 hours post-randomization, on sublingual microcirculation.(functional capillary density (FCD)) with the CytoCam-IDF imaging videomicroscope and its MicroTools software

Trial sites (1)

More University Hospital, Strasbourg, France trials in France

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