Cyclosporine In Takotsubo Syndrome
Recruiting · NCT05946772 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Heidelberg
View the official record on ClinicalTrials.gov →Interventions studied
Cyclosporine APlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 -
- Written informed consent
- Key
Exclusion criteria
- 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
- History of chronic renal insufficiency (either creatinin clearance \<30 ml/min/1.73m² or current medical care for severe renal insufficiency)
- History of liver insufficiency
- Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure \>180mmHg and/or diastolic blood pressure \>110mmHg)
- Current medication with any compound containing Hypericum perforatum (St. John's worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine (Rosuvastatine \>5mg within 24h intake\<48h before IMP administration)
- Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception
- Any disorder associated with immunological dysfunction ≤6 months prior to presentation (autoimmune disease, known positive serology for HIV or hepatitis)
- Immunosuppressive, chemotherapeutical, or antibody treatment
- Participation in other clinical trials except for non interventional trials
Where it is running
24 locations listed.
- Kerckhoff Heart Center, Bad Nauheim / Gießen University - Bad Nauheim, Germany
- Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Berlin, Germany
- Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum - Berlin, Germany
- Heart Centre - University Hospital Bonn - Bonn, Germany
- Department of Cardiology, University Hospital Köln - Cologne, Germany
- Department of Cardiology, University Hospital Dresden - Dresden, Germany
- Cardiovascular Centre - University Hospital Düsseldorf - Düsseldorf, Germany
- Department of Cardiology - University Hospital Essen - Essen, Germany
- Department of Cardiology, University Hospital Frankfurt - Frankfurt, Germany
- University Medical Center Göttingen - Göttingen, Germany
- Department of Cardiology, University Hospital Halle - Halle, Germany
- University Medical Center Hamburg-Eppendorf - Hamburg, Germany
- Department of Cardiology, Heidelberg University Hospital - Heidelberg, Germany
- Department of Cardiology, University Hospital Leipzig - Leipzig, Germany
- Leipzig Heart Center - Leipzig, Germany
- University Medical Center Schleswig-Holstein/Campus Lübeck - Lübeck, Germany
- Department of Cardiology, University Hospital Magdeburg - Magdeburg, Germany
- Department of Cardiology, University Hospital Mainz - Mainz, Germany
- Department of Cardiology, University Hospital Mannheim - Mannheim, Germany
- Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich - München, Germany
- University Hospital rechts der Isar, Technical University of Munich - München, Germany
- Department of Cardiology, University Hospital Rostock - Rostock, Germany
- Department of Cardiology, University Hospital Ulm - Ulm, Germany
- Department of Cardiology, University Hospital Wuppertal - Wuppertal, Germany