Cyclosporine A is a well known medication and is used to prevent rejection after solid organ transplantation and in the treatment of inflammatory disorders such as myocarditis.
Conditions
Brief summary
Primary efficacy endpoint: Reduction of myocardial damage quantified by AUC of centrally measured highsensitive cardiac Troponin T (TnT) over 72 h.
Detailed description
Change in TnT/NTproBNP at T3/12/24/36/48/60/72/M1 and change in LVEF at T48/72/M1 (vs. baseline), Myocardial edema/inflammation at T48-72 (cMRI, T2 SIand EGE ratio (lake louise criteria)), Length of stay on IMC/ICU and length of hospital stay, Composite cardiovascular outcome at 30d and 1year: mortality from any cause, stroke, myocardial infarction, heart failure, hospitalization, recurrent TTS, cardiac arrest / ventricular fibrillation, ventricular tachycardia, novel atrial fibrillation, thromboembolism, LV-Thrombus, AV-Block, ventricular rupture and new onset atrial fibrillation, Psychosocial and quality of life assessments between groups at M1 vs. M12
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Reduction of myocardial damage quantified by AUC of centrally measured highsensitive cardiac Troponin T (TnT) over 72 h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in TnT/NTproBNP at T3/12/24/36/48/60/72/M1 and change in LVEF at T48/72/M1 (vs. baseline), Myocardial edema/inflammation at T48-72 (cMRI, T2 SIand EGE ratio (lake louise criteria)), Length of stay on IMC/ICU and length of hospital stay, Composite cardiovascular outcome at 30d and 1year: mortality from any cause, stroke, myocardial infarction, heart failure, hospitalization, recurrent TTS, cardiac arrest / ventricular fibrillation, ventricular tachycardia, novel atrial fibrillation, thromboembolism, LV-Thrombus, AV-Block, ventricular rupture and new onset atrial fibrillation, Psychosocial and quality of life assessments between groups at M1 vs. M12 | — |
Countries
Germany