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

NCT ID: NCT07141355

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-09-30

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 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.

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 improves microcirculation, which is a known predictor of patient outcomes in CS.

Upon a patient's inclusion in the main EMPASHOCK trial, consent for this ancillary study is obtained from the patient's family, with direct patient consent sought later if their condition improves.

The study involves two data collection points:

Baseline (H0): Before empagliflozin administration, a videomicroscope is used to capture sublingual microcirculation images. These images are analyzed using MicroTools software to measure key microcirculatory parameters. Standard macrocirculatory parameters (blood pressure, cardiac output) are also recorded.

48 Hours (H48): The same microcirculatory and macrocirculatory data are collected again to assess changes following treatment.

For patients in the non-empagliflozin group, assessment will be perform at inclusion (H0) and at H48.

The study's primary outcomes are the changes in these parameters over 48 hours, along with the patient's survival status at day 28.

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

microcirculation using the video microscopy tool.

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: SHAM_COMPARATOR

microcirculation using the video microscopy tool.

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

9357

Identifier Type: -

Identifier Source: org_study_id