RecruitingPhase 3NCT05879276

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


Sponsor

Central Hospital, Nancy, France

Enrollment

164 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether starting the diabetes drug empagliflozin (an SGLT2 inhibitor) early in patients who are hospitalized for cardiogenic shock — when the heart suddenly cannot pump enough blood — can improve survival, kidney function, and heart recovery at 3 months. **You may be eligible if...** - You are an adult hospitalized in an intensive care unit or cardiac care unit for cardiogenic shock - You have been on vasopressor medications (adrenaline-like drugs) for at least 12 hours for the shock - You are able to swallow oral tablets **You may NOT be eligible if...** - Your kidney function is severely impaired (GFR below 20) - You are on chronic dialysis - You were already taking SGLT2 inhibitors before your hospitalization - You are allergic to SGLT2 inhibitors or lactose - You are taking lithium - Your shock is caused by another reason (not heart failure) or you are critically ill beyond recovery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 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.


Locations(8)

CHR Metz - Thionville

Ars-Laquenexy, France

CHU de Besançon

Besançon, France

CHU de Dijon Bourgogne

Dijon, France

CHU Lille

Lille, France

CHU Reims

Reims, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

CHRU de NANCY - réanimation médicale

Vandœuvre-lès-Nancy, France

Chru Nancy - Usic

Vandœuvre-lès-Nancy, France

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NCT05879276


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