Cyclosporine In Takotsubo Syndrome
ConditionTakotsubo Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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 criteria
Qualifiers
Patients aged over 18
Enrollment and first IMP administration within 24 hours after cardiac catheterization
Regional Wall Motion Abnormality (WMA) consistent with TTS in angiography or echocardiography
InterTAK prognostic score- or a GEIST Score ≥ 9 -
Disqualifiers
Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI)
Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion)
History of hypersensitivity to cyclosporine
History of hypersensitivity to egg, peanut or soybean proteins
Trial design
Treatments tested in this trial
- Cyclosporine A
- Placebo
Treatment groups
204 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital Heidelberg
Lead sponsor
German Centre of Cardiovascular Research (DZHK)
Collaborator
Coordinating Centre for Clinical Studies (KKS) Heidelberg
Collaborator
Source ClinicalTrials.gov