NCT05946772RecruitingPhase 2
Cyclosporine In Takotsubo Syndrome
Cyclosporine In Takotsubo Syndrome (CIT) Trial
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 19 Jun 2023
- Start date
- 1 Feb 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Heart failure
- NCT number
- NCT05946772
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 204
- From 1 Feb 2025 to the primary completion date, Feb 2027
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- History of chronic renal insufficiency (either creatinin clearance \<30 ml/min/1.73m² or current medical care for severe renal insufficiency)
Age
- Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception
Other
- Participation in other clinical trials except for non interventional trials
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kerckhoff Heart Center, Bad Nauheim / Gießen University Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Recruiting |
| Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Heart Centre - University Hospital Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Department of Cardiology, University Hospital Köln Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Department of Cardiology, University Hospital Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Cardiovascular Centre - University Hospital Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| Department of Cardiology - University Hospital Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Department of Cardiology, University Hospital Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| University Medical Center Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Recruiting |
| Department of Cardiology, University Hospital Halle Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Department of Cardiology, Heidelberg University Hospital Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Leipzig Heart Center Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Department of Cardiology, University Hospital Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| University Medical Center Schleswig-Holstein/Campus Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Department of Cardiology, University Hospital Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| Department of Cardiology, University Hospital Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Department of Cardiology, University Hospital Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| University Hospital rechts der Isar, Technical University of Munich Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Department of Cardiology, University Hospital Rostock Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Department of Cardiology, University Hospital Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Department of Cardiology, University Hospital Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.