NCT05879276RecruitingPhase 3
Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.
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
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- First submitted
- 12 Apr 2023
- Start date
- 16 Dec 2024
- Primary completion date
- 16 Mar 2027
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Heart failure
- NCT number
- NCT05879276
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 164
- From 16 Dec 2024 to the primary completion date, 16 Mar 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient on SGLT2 inhibitors prior to admission to ICU or CCU.
- 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.
Lab values
- GFR\< 20 ml/min/1.73m2.
- 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)
Age
- Women of childbearing age without effective contraception.
Other
- Chronic dialysis.
- Patients on lithium.
- Patient in shock for another cause or moribund (SAPS2\> 90).
- 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))
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHR Metz - Thionville Coordinator of this site? Confirm its status | Ars-Laquenexy | France | Recruiting |
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| CHU de Dijon - Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| CHU Reims Coordinator of this site? Confirm its status | Reims | France | Not yet recruiting |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Chru Nancy - Usic Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| CHRU de NANCY - réanimation médicale Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.