Early use of Empagliflozin in patients with cardiogenic shock

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

This study tests if starting a diabetes medication called Empagliflozin early can help people in cardiogenic shock feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (Academic / other)
• Locations: 8 sites (Ars-Laquenexy and 7 other locations)
• Trial ID: NCT05879276 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of initiating Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in patients experiencing cardiogenic shock. The study focuses on patients who have been on catecholamines for more than 12 hours but less than 5 days, assessing outcomes such as mortality, rehospitalization rates, left ventricular ejection fraction, and renal function over a three-month period. The trial aims to determine if early intervention with Empagliflozin can improve long-term prognosis in this critical patient population.

Who should consider this trial

Good fit: Ideal candidates include adult patients hospitalized for cardiogenic shock who have been on catecholamines for a specified duration.

Not a fit: Patients with severely impaired renal function, those on chronic dialysis, or those with specific contraindications to SGLT2 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and improve heart and kidney function in patients recovering from cardiogenic shock.

How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors in heart failure management, suggesting potential success for this novel application in acute settings.

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))

Where this trial is running

Ars-Laquenexy and 7 other locations

• CHR Metz - Thionville — Ars-Laquenexy, France (Recruiting)
• CHU de Besançon — Besançon, France (Recruiting)
• CHU de Dijon Bourgogne — Dijon, France (Not_yet_recruiting)
• CHU Lille — Lille, France (Not_yet_recruiting)
• CHU Reims — Reims, France (Not_yet_recruiting)
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
• CHRU de NANCY - réanimation médicale — Vandœuvre-lès-Nancy, France (Recruiting)
• Chru Nancy - Usic — Vandœuvre-lès-Nancy, France (Recruiting)

Study contacts

• Study coordinator: Antoine KIMMOUN, MD PhD

Conditions Cardiogenic Shock; Heart failure; Acute heart failure; Cardiogenic shock; SGLT2 inhibitor; Mortality