BridgeMD
New treatment option for Cardiogenic Shock
Official title Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.
ClinicalTrials.gov ID: NCT05879276
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, being studied as a potential treatment for cardiogenic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Patients on lithium.
- Patient in shock for another cause or moribund (SAPS2\> 90).
See the full eligibility 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
- 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:
- cardiac transplant patient or on transplant list.
- peripartum, adrenergic, valvular, non ischemic, post embolic heart disease.
- related to cardiotropic drug intoxication.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ars-Laquenexy, France
- Besançon, France
- Dijon, France
- Lille, France
- Reims, France
- Strasbourg, France
- Vandœuvre-lès-Nancy, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ars-Laquenexy, France; Besançon, France; Dijon, France; Lille, France; Reims, France; Strasbourg, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.