Cyclosporine In Takotsubo Syndrome

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 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.

Eligibility

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

Conditions2

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