Status:
RECRUITING
Cyclosporine In Takotsubo Syndrome
Lead Sponsor:
University Hospital Heidelberg
Collaborating Sponsors:
German Centre of Cardiovascular Research (DZHK)
Coordinating Centre for Clinical Studies (KKS) Heidelberg
Conditions:
Takotsubo Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 q...
Detailed Description
Takotsubo syndrome (TTS) has been suggested to be caused by catecholamine excess with myocardial inflammation-enhanced cardiac injury. Substantial morbidity and mortality have repeatedly been reported...
Eligibility Criteria
Inclusion Criteria:
-
Adult patients (age ≥ 18 years)
-
Symptom onset < 24h
-
With a high probability of TTS:
- InterTAK Diagnostic Score > 39 and
- Regional wall motion abnormality (WMA) consistent with TTS; no coronary intervention (PCI), or reperfused myocardial ischemia according to MRI
-
With a high probability of impaired outcome:
- InterTAK Prognostic Score >15 or
- GEIST Score > 19
Exclusion Criteria:
- Suspected infection
- Cardiac arrest, ventricular fibrillation, invasive ventilatory support
- Known hypersensitivity to CsA, egg, peanut, or soya-bean proteins
- Renal insufficiency (creatinin clearance < 30 ml/min/1.73m²)
- Liver insufficiency
- Uncontrolled hypertension (>180/110 mmHg)
- Hypericum perforatum, Stiripentol, Aliskiren, Bosentan, or Rosuvastatin treatment
- Pregnancy or women of childbearing age without contraception
- Any disorder associated with immunological dysfunction < 6 months prior to presentation
- Immunosuppressive therapy
- Participation in another clinical trial
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT05946772
Start Date
February 1 2025
End Date
February 1 2028
Last Update
April 8 2025
Active Locations (21)
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1
Kerckhoff Heart Center, Bad Nauheim / Gießen University
Bad Nauheim, Germany
2
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
3
Department of Cardiology, Charité - Universitätsmedizin Berlin
Berlin, Germany
4
Heart Centre - University Hospital Bonn
Bonn, Germany