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RECRUITING
NCT05946772
PHASE2

Cyclosporine In Takotsubo Syndrome

Sponsor: University Hospital Heidelberg

View on ClinicalTrials.gov

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

Interventions

DRUG

Cyclosporine A

2.5mg/kg body weight Cyclosporine A as an intravenous bolus

DRUG

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