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Cyclosporine In Takotsubo Syndrome

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital Heidelberg
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key inclusion criteria: * Patients aged over 18 * Enrollment and first IMP administration within 24 hours after cardiac catheterization * Regional Wall Motion Abnormality (WMA) consistent with TTS in angiography or echocardiography * InterTAK prognostic score- or a GEIST Score ≥ 9 - * Written informed consent Key exclusion Criteria: * Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI) * Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion) * History of hypersensitivity to cyclosporine * History of hypersensitivity to egg, peanut or soybean proteins * History of chronic renal insufficiency (either creatinin clearance \<30 ml/min/1.73m² or current medical care for severe renal insufficiency) * History of liver insufficiency * Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure \>180mmHg and/or diastolic blood pressure \>110mmHg) * Current medication with any compound containing Hypericum perforatum (St. John's worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine (Rosuvastatine \>5mg within 24h intake\<48h before IMP administration) * Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception * Any disorder associated with immunological dysfunction ≤6 months prior to presentation (autoimmune disease, known positive serology for HIV or hepatitis) * Immunosuppressive, chemotherapeutical, or antibody treatment * Participation in other clinical trials except for non interventional trials
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What it tests

  • Cyclosporine A
  • Placebo
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Where

24 sites
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

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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