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RecruitingPhase 2NCT05946772

Cyclosporine In Takotsubo Syndrome

Cyclosporine In Takotsubo Syndrome (CIT) Trial

Sponsor

University Hospital Heidelberg

Enrollment

204 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Takotsubo Cardiomyopathy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cyclosporine — a drug that calms the immune system — can improve outcomes in patients with Takotsubo syndrome, also known as "broken heart syndrome." This is a sudden, temporary weakening of the heart that is often triggered by extreme stress or illness. **You may be eligible if...** - You are 18 or older and your symptoms started within the last 24 hours - You have a high probability of Takotsubo syndrome based on clinical scoring systems and heart imaging showing abnormal wall motion - Your risk scores indicate a higher chance of a poor outcome **You may NOT be eligible if...** - You have a suspected infection - You have had a cardiac arrest, serious heart rhythm problems, or required mechanical ventilation - You have a known allergy to cyclosporine, eggs, peanuts, or soy - You have significant kidney or liver problems - You have severely uncontrolled high blood pressure - You are taking certain medications that interact with cyclosporine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclosporine A

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

DRUGPlacebo

The same amount of 0.9% sodium chloride (NaCl0.9%) will be applied in an indistinguishable package as an intravenous bolus

Locations(24)

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, Campus Virchow Klinikum

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

Department of Cardiology, University Hospital Frankfurt

Frankfurt, Germany

University Medical Center Göttingen

Göttingen, Germany

Department of Cardiology, University Hospital Halle

Halle, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Department of Cardiology, Heidelberg University Hospital

Heidelberg, Germany

Department of Cardiology, University Hospital Leipzig

Leipzig, 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 Rostock

Rostock, Germany

Department of Cardiology, University Hospital Ulm

Ulm, Germany

Department of Cardiology, University Hospital Wuppertal

Wuppertal, Germany

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NCT05946772

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