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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHR Metz - Thionville
RECRUITING
Ars-laquenexy
CHU de Besançon
RECRUITING
Besançon
CHU de Dijon Bourgogne
NOT_YET_RECRUITING
Dijon
CHU Lille
NOT_YET_RECRUITING
Lille
CHU Reims
NOT_YET_RECRUITING
Reims
Hôpitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
CHRU de NANCY - réanimation médicale
RECRUITING
Vandœuvre-lès-nancy
Chru Nancy - Usic
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Antoine KIMMOUN, MD PhD
a.kimmoun@chru-nancy.fr
3 83 15 40 79
Backup
Dany JANAH, MD
dany.janah@chu-lille.fr
3 20 44 59 62
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2027-03-16
Participants
Target number of participants: 164
Treatments
Experimental: 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
No_intervention: 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.
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov