Cardiogenic ShockEMPAmicroSHOCKNCT07141355
Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
A study testing microcirculation using the video microscopy tool. in people with Cardiogenic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- microcirculation using the video microscopy tool.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Hamid MERDJI, MD, 03 69 55 11 23 ext. 0033, hamid.merdji@chru-strasbourg.fr
About this study
Official title: Microcirculatory Effects of Empagliflozin in Patients With Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
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.
Read more
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.
Read the 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
- Being tested
- microcirculation using the video microscopy tool.
- Keywords
- Cardiogenic Shock, Acute Heart failure, Heart failure
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: microcirculation using the video microscopy tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Comparison between Day 0 and 48 hours
Secondary outcomes (6)
Correlation between microcirculation parameters and macrocirculation parameters.
Cardiac power index
Measured: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Total vessel density (TVD)
Measured: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Proportion of perfused vessels (PPV)
Measured: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Functional capillary density (FCD),
Measured: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Red blood cell mean velocity (RBCv)
Measured: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Per-capillary microcirculatory flow index (MFI)
Measured: Comparison between Day 0 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start12 Dec 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141355
- Sponsor's protocol ID
- 9357
- Acronym
- EMPAmicroSHOCK
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Effects of Empagliflozin in Patients With Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial
- ClinicalTrials.gov ID
- NCT07141355
- Acronym / sponsor ID
- EMPAmicroSHOCK / 9357
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic Shock, Acute Heart failure, Heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient in cardiogenic shock under empagliflozin | Active comparator | Diagnostic Test: microcirculation using the video microscopy tool.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. |
| Patient in cardiogenic shock without empagliflozin | Sham comparator | Diagnostic Test: microcirculation using the video microscopy tool.Subgroup of patients from the EMPASHOCK trial, without empagliflozin, in which microcirculation parameters will be evaluated at inclusion and again after 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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**
Key exclusion criteria (13 listed)
- • GFR < 20 ml/min/1.73m²
- Pregnant woman, woman in labor, or breastfeeding mother
- Minor person (not emancipated)
- Adult person subject to a legal protection measure (guardianship, curatorship, legal safeguard)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Patient in cardiogenic shock under empagliflozin, Patient in cardiogenic shock without empagliflozin |
Primary outcome
The difference in the evolution of a parameter reflecting the microcirculation between the two groups at 48 hours post-randomization.
Time frame: 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
6 secondary outcomes
Correlation between microcirculation parameters and macrocirculation parameters.
Time frame: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Time frame: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Time frame: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Time frame: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Time frame: Comparison between Day 0 and 48 hours
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Time frame: Comparison between Day 0 and 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microcirculation using the video microscopy tool. in people with Cardiogenic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the evolution of a parameter reflecting the microcirculation between the two groups at 48 hours post-randomization. (time frame: Comparison between Day 0 and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.