Cyclosporine In Takotsubo Syndrome

Launched by UNIVERSITY HOSPITAL HEIDELBERG · Jul 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Cyclosporine A (CsA) in patients with Takotsubo Syndrome (TTS), a condition that can cause temporary heart muscle weakening, often triggered by stress. The main goal is to see if CsA can help reduce heart damage and improve heart function in patients who are at high risk for serious outcomes. Participants will receive either CsA or a placebo (a non-active treatment) during their first day in the study, and researchers will track their health over a year to compare the two groups.

To be eligible for this trial, participants must be adults aged 18 or older who have experienced symptoms of TTS within the last 24 hours and have specific test results indicating a high likelihood of TTS and a poor expected outcome. However, there are certain conditions that would exclude someone from participating, such as having a recent infection or serious heart issues. Those who join can expect close monitoring and follow-up visits to assess their heart health throughout the study. This trial is currently recruiting participants, and it's an important step toward understanding better treatment options for TTS.

Gender

ALL

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