Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.

NCT ID: NCT05879276

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2027-03-16

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empaglifozin in addition to standard management

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

Group Type: EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type: DRUG

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.

Standard management

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Empagliflozin 10 MG

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.

Intervention Type: DRUG

Eligibility 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))

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Dr Antoine KIMMOUN

coordinating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas GIRERD, MD PhD

Role: STUDY_CHAIR

CHRU of NANCY

Locations

CHR Metz - Thionville

Ars-Laquenexy, , France

Site Status: RECRUITING

CHU de Besançon

Besançon, , France

Site Status: RECRUITING

CHU de Dijon Bourgogne

Dijon, , France

Site Status: NOT_YET_RECRUITING

CHU Lille

Lille, , France

Site Status: NOT_YET_RECRUITING

CHU Reims

Reims, , France

Site Status: NOT_YET_RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

CHRU de NANCY - réanimation médicale

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Chru Nancy - Usic

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Antoine KIMMOUN, MD PhD

Role: CONTACT

a.kimmoun@chru-nancy.fr

3 83 15 40 79 ext. +33

Dany JANAH, MD

Role: CONTACT

dany.janah@chu-lille.fr

3 20 44 59 62 ext. +33

Facility Contacts

Guillaume LOUIS, MD

Role: primary

guillaume.louis@chr-metz-thionville.fr

+33 3 87 55 31 31

Hadrien WINISZEWSKI, Md PhD

Role: primary

hwiniszewski@chu-besancon.fr

+33 3 81 66 81 66.

Jean Pierre QUENOT, MD

Role: primary

LEMESLE Gilles, MD PhD

Role: primary

gilles.lemesle@chru-lille.fr

+33 3 20 44 59 62

Bruno MOURVILLIER, MD PhD

Role: primary

Hamid MERDJI, MD PhD

Role: primary

hamid.merdji@chru-strasbourg.fr

+33 3 88 11 67 68

Antoine KIMMOUN, MD PhD

Role: primary

a.kimmoun@chru-nancy.fr

+33 3 83 85 85 85

Popovic BATRIC, MD PhD

Role: primary

b.popovic@chru-nancy.fr

+33383858585

Other Identifiers

2023PI223 - 2023-503602-37-00

Identifier Type: -

Identifier Source: org_study_id