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Study of Cyclosporine A Treatment for Takotsubo Syndrome to Reduce Heart Muscle Damage and Improve Heart Function
Led by University Hospital Heidelberg · Updated on 2026-05-01
204
Participants Needed
24
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to study the effects of repetitive acute Cyclosporine A CsA bolus therapy in patients with Takotsubo syndrome TTS who have a high risk of poor outcomes. Takotsubo syndrome may be caused by excess catecholamines leading to heart inflammation and damage. Currently, there is no proven treatment for TTS, and this phase 2 randomized controlled trial will evaluate whether CsA can reduce heart injury and improve heart function compared to placebo. Participants will be randomly assigned to receive either Cyclosporine A or a placebo intravenously at baseline, 12 hours, and 24 hours after study inclusion. The treatment is given as a bolus dose based on body weight. The study will compare these two groups to see if CsA reduces heart muscle damage and improves the hearts ejection fraction. Secondary measures include heart inflammation, hospital stay length, and quality of life over a one-year follow-up. During the study, participants will have blood tests to measure heart damage markers like Troponin T at multiple time points up to 30 days. Heart function and inflammation will be assessed through imaging and clinical evaluations. Researchers will monitor participants for cardiovascular events, symptoms, depression, anxiety, and PTSD scores at 30 days and one year. The total participation includes close monitoring during the acute phase and follow-up assessments for one year.
CONDITIONS
Brief Title
Cyclosporine In Takotsubo Syndrome
Research Team
B
Bastian Bruns, MD
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