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

NCT07141355 | Active Not Recruiting

• 1 other identifier: 9357
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Keywords

Cardiogenic Shock; Acute Heart failure; Heart failure

Outcome Measures

Primary Outcomes (1)

• The difference in the evolution of a parameter reflecting the microcirculation between the two groups at 48 hours post-randomization.

  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

  Comparison between Day 0 and 48 hours

Secondary Outcomes (6)

• Correlation between microcirculation parameters and macrocirculation parameters.

  Comparison between Day 0 and 48 hours

• The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.

  Comparison between Day 0 and 48 hours

• The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.

  Comparison between Day 0 and 48 hours

• The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.

  Comparison between Day 0 and 48 hours

• The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.

  Comparison between Day 0 and 48 hours

Study Arms (2)

Patient in cardiogenic shock under empagliflozin

ACTIVE COMPARATOR

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.

Diagnostic Test: microcirculation using the video microscopy tool.

Patient in cardiogenic shock without empagliflozin

SHAM COMPARATOR

Subgroup of patients from the EMPASHOCK trial, without empagliflozin, in which microcirculation parameters will be evaluated at inclusion and again after 48 hours.

Diagnostic Test: microcirculation using the video microscopy tool.

Interventions

microcirculation using the video microscopy tool. 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 under empagliflozin; Patient in cardiogenic shock without empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

FR (1)