Actively Recruiting
Cyclosporine In Takotsubo Syndrome
Led by University Hospital Heidelberg · Updated on 2026-05-01
204
Participants Needed
24
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University Hospital Heidelberg
Lead Sponsor
G
German Centre of Cardiovascular Research (DZHK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cyclosporine In Takotsubo Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 18
- Enrollment and first investigational medicinal product administration within 24 hours after cardiac catheterization
- Regional Wall Motion Abnormality consistent with Takotsubo syndrome in angiography or echocardiography
- InterTAK prognostic score or GEIST Score of 9 or higher
- Written informed consent
You will not qualify if you...
- Acute coronary syndrome with significant coronary stenosis or percutaneous coronary intervention
- Infection with 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 (creatinine clearance less than 30 ml/min/1.73m² or severe renal insufficiency treatment)
- History of liver insufficiency
- Uncontrolled hypertension (systolic >180 mmHg or diastolic >110 mmHg) at screening
- Current medication with Hypericum perforatum, Stiripentol, Aliskiren, Bosentan, or Rosuvastatin over 5 mg within 48 hours before treatment
- Female patients currently pregnant or women of childbearing age without negative pregnancy test or effective contraception
- Any disorder causing immunological dysfunction within 6 months prior to presentation
- Immunosuppressive, chemotherapy, or antibody treatment
- Participation in other clinical trials except non-interventional trials
AI-Screening
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Trial Site Locations
Total: 24 locations
1
Kerckhoff Heart Center, Bad Nauheim / Gießen University
Bad Nauheim, Germany
Actively Recruiting
2
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
Actively Recruiting
3
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany
Actively Recruiting
4
Heart Centre - University Hospital Bonn
Bonn, Germany
Actively Recruiting
5
Department of Cardiology, University Hospital Köln
Cologne, Germany
Actively Recruiting
6
Department of Cardiology, University Hospital Dresden
Dresden, Germany
Actively Recruiting
7
Cardiovascular Centre - University Hospital Düsseldorf
Düsseldorf, Germany
Actively Recruiting
8
Department of Cardiology - University Hospital Essen
Essen, Germany
Actively Recruiting
9
Department of Cardiology, University Hospital Frankfurt
Frankfurt, Germany
Actively Recruiting
10
University Medical Center Göttingen
Göttingen, Germany
Actively Recruiting
11
Department of Cardiology, University Hospital Halle
Halle, Germany
Actively Recruiting
12
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
13
Department of Cardiology, Heidelberg University Hospital
Heidelberg, Germany, 69120
Actively Recruiting
14
Department of Cardiology, University Hospital Leipzig
Leipzig, Germany
Actively Recruiting
15
Leipzig Heart Center
Leipzig, Germany
Actively Recruiting
16
University Medical Center Schleswig-Holstein/Campus Lübeck
Lübeck, Germany
Actively Recruiting
17
Department of Cardiology, University Hospital Magdeburg
Magdeburg, Germany
Actively Recruiting
18
Department of Cardiology, University Hospital Mainz
Mainz, Germany
Actively Recruiting
19
Department of Cardiology, University Hospital Mannheim
Mannheim, Germany
Actively Recruiting
20
Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich
München, Germany
Actively Recruiting
21
University Hospital rechts der Isar, Technical University of Munich
München, Germany
Actively Recruiting
22
Department of Cardiology, University Hospital Rostock
Rostock, Germany
Actively Recruiting
23
Department of Cardiology, University Hospital Ulm
Ulm, Germany
Actively Recruiting
24
Department of Cardiology, University Hospital Wuppertal
Wuppertal, Germany
Actively Recruiting
Research Team
B
Bastian Bruns, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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