Early use of Empagliflozin in patients with cardiogenic shock
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
Run by Central Hospital, Nancy, France · NCT05879276 · Data updated 2026-11-12
This study tests if starting a diabetes medication called Empagliflozin early can help people in cardiogenic shock feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 8 sites (Ars-Laquenexy and 7 other locations) |
| Status | Recruiting |
| Started | December 16, 2024 |
| Main results expected | March 16, 2027 |
| Study ends | March 16, 2027 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT05879276 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients hospitalized for cardiogenic shock who have been on catecholamines for a specified duration.
✕Probably not a fit
Patients with severely impaired renal function, those on chronic dialysis, or those with specific contraindications to SGLT2 inhibitors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of initiating Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in patients experiencing cardiogenic shock. The study focuses on patients who have been on catecholamines for more than 12 hours but less than 5 days, assessing outcomes such as mortality, rehospitalization rates, left ventricular ejection fraction, and renal function over a three-month period. The trial aims to determine if early intervention with Empagliflozin can improve long-term prognosis in this critical patient population.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and improve heart and kidney function in patients recovering from cardiogenic shock.
How similar studies have gone: Previous studies have shown promising results with SGLT2 inhibitors in heart failure management, suggesting potential success for this novel application in acute settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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). * Specific cardiogenic shock context: 1. cardiac transplant patient or on transplant list. 2. peripartum, adrenergic, valvular, non ischemic, post embolic heart disease. 3. related to cardiotropic drug intoxication. 4. 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))
Where it's running
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CHR Metz - Thionville
Ars-Laquenexy, France Recruiting -
CHU de Besançon
Besançon, France Recruiting -
Hôpitaux Universitaires de Strasbourg
Strasbourg, France Recruiting -
CHRU de NANCY - réanimation médicale
Vandœuvre-lès-Nancy, France Recruiting -
Chru Nancy - Usic
Vandœuvre-lès-Nancy, France Recruiting -
CHU de Dijon Bourgogne
Dijon, France Not yet recruiting
Show 2 more locations
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CHU Lille
Lille, France Not yet recruiting -
CHU Reims
Reims, France Not yet recruiting
Study contacts
- Study coordinator: Antoine KIMMOUN, MD PhD
- Email: a.kimmoun@chru-nancy.fr
- Phone: 3 83 15 40 79
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.