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Cyclosporine In Takotsubo Syndrome
Sponsor: University Hospital Heidelberg
Summary
The goal of this clinical trial is to investigate the impact of repetitive acute Cyclosporine A (CsA) bolus therapy in patients suffering from TTS with an elevated risk of impaired outcome. The main question it aims to answer is whether CsA reduces myocardial injury (primary outcome). Participants will receive CsA or placebo at baseline and every 12h in the first 24h after study inclusion. Researchers will compare CsA and the placebo group to see if a) myocardial injury is reduced, and b) ejection fraction is improved compared to baseline, as well as several other secondary endpoints over a one year follow-up.
Official title: Cyclosporine In Takotsubo Syndrome (CIT) Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2025-02-01
Completion Date
2028-02
Last Updated
2025-04-08
Healthy Volunteers
No
Conditions
Interventions
Cyclosporine A
2.5mg/kg body weight Cyclosporine A as an intravenous bolus
Placebo
The same amount of 0.9% sodium chloride (NaCl0.9%) will be applied in an indistinguishable package as an intravenous bolus
Locations (21)
Kerckhoff Heart Center, Bad Nauheim / Gießen University
Bad Nauheim, Germany
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
Department of Cardiology, Charité - Universitätsmedizin Berlin
Berlin, Germany
Heart Centre - University Hospital Bonn
Bonn, Germany
Department of Cardiology, University Hospital Köln
Cologne, Germany
Department of Cardiology, University Hospital Dresden
Dresden, Germany
Cardiovascular Centre - University Hospital Düsseldorf
Düsseldorf, Germany
Department of Cardiology - University Hospital Essen
Essen, Germany
University Medical Center Göttingen
Göttingen, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Department of Cardiology, University Hospital Hannover
Hanover, Germany
Department of Cardiology, Heidelberg University Hospital
Heidelberg, Germany
University Medical Center Schleswig-Holstein/Campus Kiel
Kiel, Germany
Leipzig Heart Center
Leipzig, Germany
University Medical Center Schleswig-Holstein/Campus Lübeck
Lübeck, Germany
Department of Cardiology, University Hospital Magdeburg
Magdeburg, Germany
Department of Cardiology, University Hospital Mainz
Mainz, Germany
Department of Cardiology, University Hospital Mannheim
Mannheim, Germany
Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich
München, Germany
University Hospital rechts der Isar, Technical University of Munich
München, Germany
Department of Cardiology, University Hospital Ulm
Ulm, Germany