Using Cyclosporine to treat Takotsubo Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of repetitive acute Cyclosporine A (CsA) bolus therapy in patients with Takotsubo syndrome (TTS) who are at high risk for poor outcomes. Participants will receive either CsA or a placebo within the first 24 hours of symptom onset, with the primary goal of assessing whether CsA can reduce myocardial injury and improve cardiac function. The study will also evaluate secondary outcomes such as hospital stay length and quality of life over a one-year follow-up period. The trial is designed as a multicenter randomized controlled trial to provide robust data on the efficacy of CsA in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Kerckhoff Heart Center, Bad Nauheim / Gießen University
  Bad Nauheim, Germany Recruiting
• Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
  Berlin, Germany Recruiting
• Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
  Berlin, Germany Recruiting
• Heart Centre - University Hospital Bonn
  Bonn, Germany Recruiting
• Department of Cardiology, University Hospital Köln
  Cologne, Germany Recruiting
• Department of Cardiology, University Hospital Dresden
  Dresden, Germany Recruiting

Study contacts

• Principal investigator: Norbert Frey, MD — University Hospital Heidelberg
• Study coordinator: Bastian Bruns, MD
• Email: bastian.bruns@med.uni-heidelberg.de
• Phone: +496221-56-36266

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.