Effect of Early Empagliflozin Initiation in Cardiogenic Shock. (NCT07450417) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Early Empagliflozin Initiation in Cardiogenic Shock.
France418 participantsStarted 2025-03-10
Plain-language summary
Cardiogenic shock represents a severe condition of heart pump dysfunction. Despite advances in medical management, the mortality rate for this condition remains high. Conventional treatments for cardiovascular diseases have several side effects that make their use impossible in patients with cardiogenic shock.
A new class of drugs has been developed in recent years and is an integral part of the management of patients with chronic heart failure. These are sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), namely empagliflozin and dapagliflozin. This therapeutic class has proven effective in reducing mortality as well as hospital readmissions for heart failure patients. Given their effectiveness in acute heart failure, which is physiologically closest to the cardiogenic shock population, and their good tolerance, SGLT2 inhibitors are increasingly being prescribed to patients with cardiogenic shock to improve long-term outcomes.
In order to improve medical knowledge and the management of patients in cardiogenic shock, the main objective of this research is to compare, in these patients, the effect of the early introduction of treatment with sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), in addition to usual care, versus usual care alone, on all-cause mortality and rehospitalization for heart failure at 12 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients over 18 years old;
* Hospitalized in an Intensive Care or Cardiac Intensive Care unit in cardiogenic shock;
* Hospitalized at CHRU of NANCY between 01/01/2018 and 31/12/2023.
Exclusion Criteria:
At admission to intensive care/cardiac intensive care for cardiogenic shock:
* eGFR \< 20 ml/min/1.73m²
* Chronic dialysis patient
* Patient on SGLT2 inhibitors prior to admission to intensive care or cardiac intensive care
* Cardiogenic shock:
* a) From peripartum cardiomyopathy, adrenergic, restrictive, or post-embolic
* b) Due to drug-induced cardiotoxicity
* c) Secondary to a cardiac arrest with more than 25 minutes of "low flow" or more than 5 minutes of "no flow" before recovery of stable cardiac activity
* Adult subject under a legal protective measure (guardianship, curatorship, judicial safeguard)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)