BridgeMD
New treatment option for Takotsubo Cardiomyopathy
Official title Cyclosporine In Takotsubo Syndrome
ClinicalTrials.gov ID: NCT05946772
What this study is testing
What is Cyclosporine A?
Cyclosporine A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for takotsubo cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary...
- 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
See the full eligibility 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
- 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 treatment trials
The study team makes the final eligibility decision.
Where it's taking place
- Bad Nauheim, Germany
- Berlin, Germany
- Bonn, Germany
- Cologne, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Frankfurt, Germany
- Göttingen, Germany
- Halle, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Leipzig, Germany
- Lübeck, Germany
- Magdeburg, Germany
- Mainz, Germany
- Mannheim, Germany
- München, Germany
- Rostock, Germany
- Ulm, Germany
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bad Nauheim, Germany; Berlin, Germany; Bonn, Germany; Cologne, Germany; Dresden, Germany; Düsseldorf, Germany and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.