Cardiogenic ShockPhase 3EMPASHOCKNCT05879276
Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.
A Phase 3 study testing Empagliflozin 10 MG in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 8 sites in France.
Trial summary
Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that… 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?
- Empagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 8 sitesFrance
- Study dates
- 16 Dec 2024to 16 Mar 2027
- Phase
- Phase 3
- 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
- Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
- "Who must have been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock.
- Patients who are able to take oral tablets
Who cannot join
- GFR< 20 ml/min/1.73m2.
- Chronic dialysis.
- Patient on SGLT2 inhibitors prior to admission to ICU or CCU.
- Known allergy to SGLT2 inhibitors or to any of its excipients (in particular, patients with hereditary disorders of galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome)
- Patients on lithium.
- Patient in shock for another cause or moribund (SAPS2> 90).
Show all 13Show fewer
- Specific cardiogenic shock context:
- cardiac transplant patient or on transplant list.
- peripartum, adrenergic, valvular, non ischemic, post embolic heart disease.
- related to cardiotropic drug intoxication.
- Secondary to a cardiac arrest for which the patient remains comatose prior to inclusion.
- Women of childbearing age without effective contraception.
- Person referred to in Articles 10, 31, 32, 33 and 34 of EU Regulation 536/2014 (Pregnant woman, parturient or breastfeeding mother, Minor (not emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice))
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHR Metz - Thionville
Ars-Laquenexy, 57000
Guillaume LOUIS, MD, +33 3 87 55 31 31, guillaume.louis@chr-metz-thionville.fr
Guillaume LOUIS, MD
- Recruiting
CHU de Besançon
Besançon, 25000
Hadrien WINISZEWSKI, Md PhD, +33 3 81 66 81 66., hwiniszewski@chu-besancon.fr
Hadrien WINISZEWSKI, MD PhD
- Not yet recruiting
CHU de Dijon Bourgogne
Dijon, 21000
Jean Pierre QUENOT, MD
Jean Pierre QUENOT, MD PhD
- Not yet recruiting
CHU Lille
Lille, 59000
LEMESLE Gilles, MD PhD, +33 3 20 44 59 62, gilles.lemesle@chru-lille.fr
Gilles LEMESLE, MD pHD
- Not yet recruiting
CHU Reims
Reims, 51000
Bruno MOURVILLIER, MD PhD
Bruno MOURVILLIER, MD PhD
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Hamid MERDJI, MD PhD, +33 3 88 11 67 68, hamid.merdji@chru-strasbourg.fr
Hamid MERDJI, MD PhD
- Recruiting
CHRU de NANCY - réanimation médicale
Vandœuvre-lès-Nancy, 54500
Antoine KIMMOUN, MD PhD, +33 3 83 85 85 85, a.kimmoun@chru-nancy.fr
Antoine KIMMOUN, MD PhD
- Recruiting
Chru Nancy - Usic
Vandœuvre-lès-Nancy, 54500
Popovic BATRIC, MD PhD, +33383858585, b.popovic@chru-nancy.fr
Batric POPOVIC, MD pHD
About this study
Official title: Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. A Randomized Multicentric Open Trial
Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock.
Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.
- Conditions
- Cardiogenic Shock
- Being tested
- Empagliflozin 10 MG
- Keywords
- Heart failure, Acute heart failure, Cardiogenic shock, SGLT2 inhibitor, Mortality
- 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.
Empagliflozin 10 MGDrug
Patients in cardiogenic shock receiving empagliflozin in addition to standard management at a dose of 10 mg per day per os (or through nasogastric tube in intubated patients) for a duration of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Empaglifozin in addition to standard management | Experimental | Patients in cardiogenic shock receiving empagliflozin in addition to standard management at a dose of 10 mg per day per os (or through nasogastric tube in intubated patients) for a duration of 12 weeks Receives: Drug: Empagliflozin 10 MG |
| Standard management | No intervention | Patients in cardiogenic shock receiving a standard management. SGLT2 inhibitor, which are now standard of care in chronic heart failure, in the strict respect of their indications, could be prescribed in the standard management group after hospitalization discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause death
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:
- All-cause mortality or heart transplantation or ventricular assist,
- Rehospitalization for heart failure,
- Left ventricular ejection fraction.
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):
- Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
- Rank 2: Time to rehospitalization for heart failure,
- Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Measured: 12-week after randomisation
Time to cardiac transplantation
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:
- All-cause mortality or heart transplantation or ventricular assist,
- Rehospitalization for heart failure,
- Left ventricular ejection fraction.
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):
- Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
- Rank 2: Time to rehospitalization for heart failure,
- Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Measured: 12-week after randomisation
Time to mechanical ventricular assist
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:
- All-cause mortality or heart transplantation or ventricular assist,
- Rehospitalization for heart failure,
- Left ventricular ejection fraction.
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):
- Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
- Rank 2: Time to rehospitalization for heart failure,
- Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Measured: 12-week after randomisation
Time to rehospitalization for heart failure.
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:
- All-cause mortality or heart transplantation or ventricular assist,
- Rehospitalization for heart failure,
- Left ventricular ejection fraction.
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):
- Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
- Rank 2: Time to rehospitalization for heart failure,
- Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Measured: 12-week after randomisation
Left ventricular ejection fraction assessed by cardiac ultrasound.
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:
- All-cause mortality or heart transplantation or ventricular assist,
- Rehospitalization for heart failure,
- Left ventricular ejection fraction.
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):
- Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
- Rank 2: Time to rehospitalization for heart failure,
- Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Measured: 12-week after randomisation
Secondary outcomes (16)
Death
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on all-cause mortality at 12 weeks from randomization
Measured: 12-week after randomisation
Heart transplantation or long-term ventricular assistance
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on heart transplantation or long-term ventricular assistance, at 12 weeks from randomization
Measured: 12-week after randomisation
Rehospitalization for heart failure
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on rehospitalization for heart failure, at 12 weeks from randomization
Measured: from hospital discharge to 12-week after randomisation
Left ventricular ejection fraction assessed by cardiac ultrasound.
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on left ventricular ejection fraction, at 12 weeks from randomization.
Measured: 12-week after randomisation
E' wave assessed by cardiac ultrasound
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the left ventricular diastolic function and filling pressures, at 12 weeks from randomization.
Measured: 12-week after randomisation
E/e' ratio assessed by cardiac ultrasound
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the left ventricular diastolic function and filling pressures, at 12 weeks from randomization.
Measured: 12-week after randomisation
TAPSE assessed by cardiac ultrasound
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the right ventricular function, at 12 weeks from randomization
Measured: 12-week after randomisation
S wave at the annular tricuspid level assessed by cardiac ultrasound
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the right ventricular function, at 12 weeks from randomization
Measured: 12-week after randomisation
Renal replacement therapy
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the renal function, at 12 weeks from randomization
Measured: Randomisation and 12-week after randomisation
Renal function
The number of patients requiring renal replacement therapy between randomization and 12 weeks, and change in renal function assessed at baseline and 12 weeks: glomerular filtration rate calculated by the CKD-EPI method
Measured: Randomisation and 12-week after randomisation
Bilirubin
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization
Measured: Randomisation and 12-week after randomisation
Prothrombin Ratio (PT)
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization
Measured: Randomisation and 12-week after randomisation
SGOT
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization
Measured: Randomisation and 12-week after randomisation
SGPT
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization
Measured: Randomisation and 12-week after randomisation
NT-Pro-BNP
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the evolution of the hydro-sodic overload, at 12 weeks from randomization. The measure of NT-Pro-BNP will be measured at 12 weeks and delta from randomisation will be calculated
Measured: Randomisation and 12-week after randomisation
Weight
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the evolution of the hydro-sodic overload, at 12 weeks from randomization. The weight will be measured at 12 weeks and delta from randomisation will be calculated
Measured: Randomisation and 12-week after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start16 Dec 2024
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Mar 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 Central Hospital, Nancy, 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, interregional, randomised, controlled, open-label clinical trial evaluating the effect of early initiation of a SGLT2 inhibitor i.e Empaglifozin, in cardiogenic shock.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Antoine KIMMOUN, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, MD PhD, Study chair, CHRU of NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879276
- Sponsor's protocol ID
- 2023PI223 - 2023-503602-37-00
- Acronym
- EMPASHOCK
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. A Randomized Multicentric Open Trial
- ClinicalTrials.gov ID
- NCT05879276
- Acronym / sponsor ID
- EMPASHOCK / 2023PI223 - 2023-503602-37-00
- Conditions
- Cardiogenic Shock
- Keywords
- Heart failure, Acute heart failure, Cardiogenic shock, SGLT2 inhibitor, Mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 30 May 2023 (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.
Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock.
Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, interregional, randomised, controlled, open-label clinical trial evaluating the effect of early initiation of a SGLT2 inhibitor i.e Empaglifozin, in cardiogenic shock.
| Arm | Type | Receives |
|---|---|---|
| Empaglifozin in addition to standard management | Experimental | Drug: Empagliflozin 10 MGPatients in cardiogenic shock receiving empagliflozin in addition to standard management at a dose of 10 mg per day per os (or through nasogastric tube in intubated patients) for a duration of 12 weeks |
| Standard management | No intervention | –Patients in cardiogenic shock receiving a standard management. SGLT2 inhibitor, which are now standard of care in chronic heart failure, in the strict respect of their indications, could be prescribed in the standard management group after hospitalization discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
- "Who must have been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock.
- Patients who are able to take oral tablets
Key exclusion criteria (13 listed)
- GFR< 20 ml/min/1.73m2.
- Chronic dialysis.
- Patient on SGLT2 inhibitors prior to admission to ICU or CCU.
- Known allergy to SGLT2 inhibitors or to any of its excipients (in particular, patients with hereditary disorders of galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome)
- Patients on lithium.
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 |
|---|---|---|
| Empagliflozin 10 MGPatients in cardiogenic shock receiving empagliflozin in addition to standard management at a dose of 10 mg per day per os (or through nasogastric tube in intubated patients) for a duration of 12 weeks. | Drug | Empaglifozin in addition to standard management |
Primary outcome
Time to all-cause death
Time frame: 12-week after randomisation
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Time to cardiac transplantation
Time frame: 12-week after randomisation
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Time to mechanical ventricular assist
Time frame: 12-week after randomisation
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Time to rehospitalization for heart failure.
Time frame: 12-week after randomisation
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
Left ventricular ejection fraction assessed by cardiac ultrasound.
Time frame: 12-week after randomisation
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
16 secondary outcomes
Death
Time frame: 12-week after randomisation
Heart transplantation or long-term ventricular assistance
Time frame: 12-week after randomisation
Rehospitalization for heart failure
Time frame: from hospital discharge to 12-week after randomisation
Left ventricular ejection fraction assessed by cardiac ultrasound.
Time frame: 12-week after randomisation
E' wave assessed by cardiac ultrasound
Time frame: 12-week after randomisation
E/e' ratio assessed by cardiac ultrasound
Time frame: 12-week after randomisation
TAPSE assessed by cardiac ultrasound
Time frame: 12-week after randomisation
S wave at the annular tricuspid level assessed by cardiac ultrasound
Time frame: 12-week after randomisation
Renal replacement therapy
Time frame: Randomisation and 12-week after randomisation
Renal function
Time frame: Randomisation and 12-week after randomisation
Bilirubin
Time frame: Randomisation and 12-week after randomisation
Prothrombin Ratio (PT)
Time frame: Randomisation and 12-week after randomisation
SGOT
Time frame: Randomisation and 12-week after randomisation
SGPT
Time frame: Randomisation and 12-week after randomisation
NT-Pro-BNP
Time frame: Randomisation and 12-week after randomisation
Weight
Time frame: Randomisation and 12-week after randomisation
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 27 Jun 2025.
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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.
Nicolas GIRERD, MD PhD study chair
CHRU of NANCY
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin 10 MG in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 8 sites 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 3 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Antoine KIMMOUN, MD PhD (3 83 15 40 79 ext. +33, a.kimmoun@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to all-cause death (time frame: 12-week after randomisation). The study lists 5 primary outcomes in all. 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 27 Jun 2025.