Using Cyclosporine to treat Takotsubo Syndrome
Cyclosporine In Takotsubo Syndrome (CIT) Trial
This study is testing if a medication called Cyclosporine can help people with Takotsubo syndrome recover better and have less heart damage compared to those who get a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 24 sites (Bad Nauheim and 23 other locations) |
| Trial ID | NCT05946772 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with recent onset Takotsubo syndrome and a high risk of impaired outcomes.
Not a fit: Patients with suspected infections, severe cardiac conditions, or contraindications to Cyclosporine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new evidence-based option for managing Takotsubo syndrome and improving patient outcomes.
How similar studies have performed: While this approach is novel in the context of Takotsubo syndrome, previous studies have shown promise for Cyclosporine in related cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bad Nauheim and 23 other locations
- 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)
- Cardiovascular Centre - University Hospital Düsseldorf — Düsseldorf, Germany (Recruiting)
- Department of Cardiology - University Hospital Essen — Essen, Germany (Recruiting)
- Department of Cardiology, University Hospital Frankfurt — Frankfurt, Germany (Recruiting)
- University Medical Center Göttingen — Göttingen, Germany (Recruiting)
- Department of Cardiology, University Hospital Halle — Halle, Germany (Recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Department of Cardiology, Heidelberg University Hospital — Heidelberg, Germany (Recruiting)
- Department of Cardiology, University Hospital Leipzig — Leipzig, Germany (Recruiting)
- Leipzig Heart Center — Leipzig, Germany (Recruiting)
- University Medical Center Schleswig-Holstein/Campus Lübeck — Lübeck, Germany (Recruiting)
- Department of Cardiology, University Hospital Magdeburg — Magdeburg, Germany (Recruiting)
- Department of Cardiology, University Hospital Mainz — Mainz, Germany (Recruiting)
- Department of Cardiology, University Hospital Mannheim — Mannheim, Germany (Recruiting)
- Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich — München, Germany (Recruiting)
- University Hospital rechts der Isar, Technical University of Munich — München, Germany (Recruiting)
- Department of Cardiology, University Hospital Rostock — Rostock, Germany (Recruiting)
- Department of Cardiology, University Hospital Ulm — Ulm, Germany (Recruiting)
- Department of Cardiology, University Hospital Wuppertal — Wuppertal, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.