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

Central Hospital, Nancy, France

Status and phase: Enrolling; Phase 3

Conditions: Cardiogenic Shock

Treatments: Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05879276

2023PI223 - 2023-503602-37-00

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Empaglifozin in addition to standard management

Experimental group

Description:

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

Treatment:

Drug: Empagliflozin 10 MG

Standard management

No Intervention group

Description:

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.