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:

  1. Adult patients (age ≥ 18 years)

  2. Symptom onset < 24h

  3. With a high probability of TTS:

    1. InterTAK Diagnostic Score > 39 and
    2. Regional wall motion abnormality (WMA) consistent with TTS; no coronary intervention (PCI), or reperfused myocardial ischemia according to MRI
  4. With a high probability of impaired outcome:

    1. InterTAK Prognostic Score >15 or
    2. GEIST Score > 19

Exclusion Criteria:

  1. Suspected infection
  2. Cardiac arrest, ventricular fibrillation, invasive ventilatory support
  3. Known hypersensitivity to CsA, egg, peanut, or soya-bean proteins
  4. Renal insufficiency (creatinin clearance < 30 ml/min/1.73m²)
  5. Liver insufficiency
  6. Uncontrolled hypertension (>180/110 mmHg)
  7. Hypericum perforatum, Stiripentol, Aliskiren, Bosentan, or Rosuvastatin treatment
  8. Pregnancy or women of childbearing age without contraception
  9. Any disorder associated with immunological dysfunction < 6 months prior to presentation
  10. Immunosuppressive therapy
  11. 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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Page 1 of 6 (21 locations)

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

Cyclosporine In Takotsubo Syndrome | DecenTrialz