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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Time to all-cause death — 12-week after randomisation
  To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
• Time to cardiac transplantation — 12-week after randomisation
  To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
• Time to mechanical ventricular assist — 12-week after randomisation
  To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
• Time to rehospitalization for heart failure. — 12-week after randomisation
  To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.
• Left ventricular ejection fraction assessed by cardiac ultrasound. — 12-week after randomisation
  To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1. All-cause mortality or heart transplantation or ventricular assist, 2. Rehospitalization for heart failure, 3. Left ventricular ejection fraction. Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): * Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist, * Rank 2: Time to rehospitalization for heart failure, * Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.

Trial sites (8)

More Central Hospital, Nancy, France trials in France

Other trials for the same condition