Cardiogenic ShockEMPASHOCKRETRONCT07450417
Effect of Early Empagliflozin Initiation in Cardiogenic Shock.
An observational study of Cardiogenic Shock, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Cardiogenic shock represents a severe condition of heart pump dysfunction. Despite advances in medical management, the mortality rate for this condition remains high. Conventional treatments for cardiovascular diseases have several side effects that make their use impossible in patients with cardiogenic shock. 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?
- Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.
- How many people
- 418 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to Apr 2026
- Phase
- Observational
- 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
Study population: Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock.
Who may be able to join
- Patients over 18 years old;
- Hospitalized in an Intensive Care or Cardiac Intensive Care unit in cardiogenic shock;
- Hospitalized at CHRU of NANCY between 01/01/2018 and 31/12/2023.
Who cannot join
- At admission to intensive care/cardiac intensive care for cardiogenic shock:
- eGFR < 20 ml/min/1.73m²
- Chronic dialysis patient
- Patient on SGLT2 inhibitors prior to admission to intensive care or cardiac intensive care
- Cardiogenic shock:
- a) From peripartum cardiomyopathy, adrenergic, restrictive, or post-embolic
Show all 9Show fewer
- b) Due to drug-induced cardiotoxicity
- c) Secondary to a cardiac arrest with more than 25 minutes of "low flow" or more than 5 minutes of "no flow" before recovery of stable cardiac activity
- Adult subject under a legal protective measure (guardianship, curatorship, judicial safeguard)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality and Rehospitalization. Retrospective Monocentric Trial.
Cardiogenic shock represents a severe condition of heart pump dysfunction. Despite advances in medical management, the mortality rate for this condition remains high. Conventional treatments for cardiovascular diseases have several side effects that make their use impossible in patients with cardiogenic shock.
A new class of drugs has been developed in recent years and is an integral part of the management of patients with chronic heart failure. These are sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), namely empagliflozin and dapagliflozin. This therapeutic class has proven effective in reducing mortality as well as hospital readmissions for heart failure patients. Given their effectiveness in acute heart failure, which is physiologically closest to the cardiogenic shock population, and their good tolerance, SGLT2 inhibitors are increasingly being prescribed to patients with cardiogenic shock to improve long-term outcomes.
In order to improve medical knowledge and the management of patients in cardiogenic shock, the main objective of this research is to compare, in these patients, the effect of the early introduction of treatment with sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), in addition to usual care, versus usual care alone, on all-cause mortality and rehospitalization for heart failure at 12 weeks.
- Conditions
- Cardiogenic Shock
- Being tested
- Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.
- Keywords
- heart failure, acute heart failure, 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.
Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.Drug
Patient in cardiogenic shock hospitalized and treated or not early with SGLT2 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Patient in cardiogenic shock | Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock and treated or not early with SGLT2 inhibitors. Receives: Drug: Patient in cardiogenic shock treated or not early with SGLT2 inhibitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: 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: 1- All-cause mortality 2-rehospitalization for heart failure
Measured: 12 weeks
Secondary outcomes (4)
Time to 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
Measured: 12 weeks
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 time to rehospitalization for heart failure, at 12 weeks
Measured: 12 weeks
KDIGO score
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on Acute kidney injury onset defined by the maximal KDIGO score reached in intensive care unit.
Measured: from admission to 90 days post admission
Renal replacement therapy
To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on renal replacement therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start10 Mar 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 418 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 de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450417
- Sponsor's protocol ID
- 2022PI106
- Acronym
- EMPASHOCKRETRO
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2025
- Last updated
- 4 Mar 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 4 Mar 2026. 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 and Rehospitalization. Retrospective Monocentric Trial.
- ClinicalTrials.gov ID
- NCT07450417
- Acronym / sponsor ID
- EMPASHOCKRETRO / 2022PI106
- Conditions
- Cardiogenic Shock
- Keywords
- heart failure, acute heart failure, SGLT2 inhibitor, Mortality
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 4 Mar 2026 (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.
Cardiogenic shock represents a severe condition of heart pump dysfunction. Despite advances in medical management, the mortality rate for this condition remains high. Conventional treatments for cardiovascular diseases have several side effects that make their use impossible in patients with cardiogenic shock.
A new class of drugs has been developed in recent years and is an integral part of the management of patients with chronic heart failure. These are sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), namely empagliflozin and dapagliflozin. This therapeutic class has proven effective in reducing mortality as well as hospital readmissions for heart failure patients. Given their effectiveness in acute heart failure, which is physiologically closest to the cardiogenic shock population, and their good tolerance, SGLT2 inhibitors are increasingly being prescribed to patients with cardiogenic shock to improve long-term outcomes.
In order to improve medical knowledge and the management of patients in cardiogenic shock, the main objective of this research is to compare, in these patients, the effect of the early introduction of treatment with sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), in addition to usual care, versus usual care alone, on all-cause mortality and rehospitalization for heart failure at 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in cardiogenic shock | – | Drug: Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock and treated or not early with SGLT2 inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock.
Key inclusion criteria (3 listed)
- Patients over 18 years old;
- Hospitalized in an Intensive Care or Cardiac Intensive Care unit in cardiogenic shock;
- Hospitalized at CHRU of NANCY between 01/01/2018 and 31/12/2023.
Key exclusion criteria (9 listed)
- eGFR < 20 ml/min/1.73m²
- Chronic dialysis patient
- Patient on SGLT2 inhibitors prior to admission to intensive care or cardiac intensive care
- Cardiogenic shock:
- a) From peripartum cardiomyopathy, adrenergic, restrictive, or post-embolic
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 |
|---|---|---|
| Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.Patient in cardiogenic shock hospitalized and treated or not early with SGLT2 inhibitors | Drug | Patient in cardiogenic shock |
Primary outcome
Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)
Time frame: 12 weeks
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 2-rehospitalization for heart failure
4 secondary outcomes
Time to death
Time frame: 12 weeks
time to rehospitalization for heart failure
Time frame: 12 weeks
KDIGO score
Time frame: from admission to 90 days post admission
Renal replacement therapy
Time frame: 12 weeks
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 4 Mar 2026.
Related trials for Cardiogenic Shock
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
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. This study is not recruiting at the moment.
Nicolas GIRERD, MD PHD study chair
CHRU de NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Central Hospital, Nancy, 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure) (time frame: 12 weeks). 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 4 Mar 2026.