Clinical trial Recruiting at 5 sites Phase 3 Interventional Ages 18 and up

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.

More Cardiogenic Shock trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment164 (estimated)
SponsorCentral Hospital, Nancy, France
Academic / other
Locations8 sites (Ars-Laquenexy and 7 other locations)
StatusRecruiting
StartedDecember 16, 2024
Main results expectedMarch 16, 2027
Study endsMarch 16, 2027
Registry record updatedJune 27, 2025
Trial IDNCT05879276 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

  • 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
  • CHU Lille
    Lille, France
    Not yet recruiting
  • CHU Reims
    Reims, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.