NCT05946772 Cyclosporine In Takotsubo Syndrome
| NCT ID | NCT05946772 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital Heidelberg |
| Condition | Takotsubo Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 204 participants in total. It began in 2025-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Key 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
Contact & Investigator
Norbert Frey, MD
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT05946772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Takotsubo Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05946772 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05946772 currently recruiting?
Yes, NCT05946772 is actively recruiting participants. Contact the research team at bastian.bruns@med.uni-heidelberg.de for enrollment information.
Where is the NCT05946772 trial being conducted?
This trial is being conducted at Bad Nauheim, Germany, Berlin, Germany, Berlin, Germany, Bonn, Germany and 11 additional locations.
Who is sponsoring the NCT05946772 clinical trial?
NCT05946772 is sponsored by University Hospital Heidelberg. The principal investigator is Norbert Frey, MD at University Hospital Heidelberg. The trial plans to enroll 204 participants.