Rationale and design of the cyclosporine in Takotsubo syndrome (CIT) trial.
Bastian Bruns, Nesrin Elsous, Ina Burghaus...
https://pubmed.ncbi.nlm.nih.gov/40268179Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05946772
Cyclosporine In Takotsubo Syndrome (CIT) Trial
Led by University Hospital Heidelberg · Updated on 2026-05-01
204
Participants Needed
24
Research Sites
52 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
This research aims to study the effects of repetitive acute Cyclosporine A (CsA) bolus therapy in patients with Takotsubo syndrome (TTS) who have a high risk of poor outcomes. Takotsubo syndrome may be caused by excess catecholamines leading to heart inflammation and damage. Currently, there is no proven treatment for TTS, and this phase 2 randomized controlled trial will evaluate whether CsA can reduce heart injury and improve heart function compared to placebo. Participants will be randomly assigned to receive either Cyclosporine A or a placebo intravenously at baseline, 12 hours, and 24 hours after study inclusion. The treatment is given as a bolus dose based on body weight. The study will compare these two groups to see if CsA reduces heart muscle damage and improves the heart's ejection fraction. Secondary measures include heart inflammation, hospital stay length, and quality of life over a one-year follow-up. During the study, participants will have blood tests to measure heart damage markers like Troponin T at multiple time points up to 30 days. Heart function and inflammation will be assessed through imaging and clinical evaluations. Researchers will monitor participants for cardiovascular events, symptoms, depression, anxiety, and PTSD scores at 30 days and one year. The total participation includes close monitoring during the acute phase and follow-up assessments for one year.
CONDITIONS
Brief Title
Cyclosporine In Takotsubo Syndrome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years
- Enrollment and first investigational medicinal product (IMP) 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 provided
You will not qualify if you...
- Acute coronary syndrome with significant coronary stenosis or percutaneous coronary intervention
- Current infection with positive blood culture
- Known allergy to cyclosporine
- Known allergy to egg, peanut, or soybean proteins
- Chronic renal insufficiency with creatinine clearance below 30 ml/min/1.73m² or under medical care for severe renal insufficiency
- Liver insufficiency
- Uncontrolled high blood pressure at screening (systolic >180 mmHg or diastolic >110 mmHg)
- Current medication with Hypericum perforatum, Stiripentol, Aliskiren, Bosentan, or Rosuvastatin above specified doses
- Female patients who are pregnant or of childbearing age without negative pregnancy test or effective contraception
- Immunological disorders within 6 months prior to presentation including autoimmune disease or positive HIV/hepatitis serology
- Use of immunosuppressive, chemotherapy, or antibody treatments
- Participation in other clinical trials except non-interventional ones
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 hours
Participants receive intravenous bolus doses of Cyclosporine A or placebo at baseline, 12 hours, and 24 hours after enrollment to assess effects on myocardial damage and cardiac function.
3 dosing visits within 24 hours
Follow-up
Duration - 1 year
Participants are monitored for recovery of cardiac function, symptom burden, psychosocial assessments, and clinical outcomes including cardiovascular events up to 1 year after treatment.
Follow-up visits at 30 days and 1 year
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
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Research Team
B
Bastian Bruns, MD
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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