Cyclosporine Tested in Takotsubo Syndrome Patients at Higher Risk
Tests cyclosporine against placebo in adults with Takotsubo syndrome at higher risk.
Plain-language title generated from the registry record
Registry title: Cyclosporine In Takotsubo Syndrome
Key facts
- Where
- Bad Nauheim, Berlin, Bonn, Cologne, Dresden, Düsseldorf, Essen, Frankfurt, Göttingen, Halle, Hamburg, Heidelberg, Leipzig, Lübeck, Magdeburg, Mainz, Mannheim, München, Rostock, Ulm, and Wuppertal, GermanySee the 24 sites
- Phase
- Phase 2
Where in Germany
- Kerckhoff Heart Center, Bad Nauheim / Gießen UniversityBad Nauheim, GermanyTaking people
- Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin FranklinBerlin, GermanyTaking people
- Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow KlinikumBerlin, GermanyTaking people
- Heart Centre - University Hospital BonnBonn, GermanyTaking people
- Department of Cardiology, University Hospital KölnCologne, GermanyTaking people
- Department of Cardiology, University Hospital DresdenDresden, GermanyTaking people
- Cardiovascular Centre - University Hospital DüsseldorfDüsseldorf, GermanyTaking people
- Department of Cardiology - University Hospital EssenEssen, GermanyTaking people
- Department of Cardiology, University Hospital FrankfurtFrankfurt, GermanyTaking people
- University Medical Center GöttingenGöttingen, GermanyTaking people
- Department of Cardiology, University Hospital HalleHalle, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Department of Cardiology, Heidelberg University HospitalHeidelberg, GermanyTaking people
- Department of Cardiology, University Hospital LeipzigLeipzig, GermanyTaking people
- Leipzig Heart CenterLeipzig, GermanyTaking people
- University Medical Center Schleswig-Holstein/Campus LübeckLübeck, GermanyTaking people
- Department of Cardiology, University Hospital MagdeburgMagdeburg, GermanyTaking people
- Department of Cardiology, University Hospital MainzMainz, GermanyTaking people
- Department of Cardiology, University Hospital MannheimMannheim, GermanyTaking people
- Department of Cardiology, Hospital of the Ludwig-Maximilians-University MunichMünchen, GermanyTaking people
- University Hospital rechts der Isar, Technical University of MunichMünchen, GermanyTaking people
- Department of Cardiology, University Hospital RostockRostock, GermanyTaking people
- Department of Cardiology, University Hospital UlmUlm, GermanyTaking people
- Department of Cardiology, University Hospital WuppertalWuppertal, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Heidelberg
- Trial code
- NCT05946772
- Record updated
- 1 May 2026
- Original description
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.Read full original descriptionShow less
Cyclosporine In Takotsubo Syndrome (CIT) Trial
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.
Inclusion: 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.
Exclusion: Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion); 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); 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; Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI); History of hypersensitivity to cyclosporine; History of hypersensitivity to egg, peanut or soybean proteins; History of liver insufficiency; Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg); History of chronic renal insufficiency (either creatinin clearance <30 ml/min/1.73m² or current medical care for severe renal insufficiency); Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception; Participation in other clinical trials except for non interventional trials.