Study on the Effects of Cyclosporine A in Patients with Takotsubo Syndrome

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What is this study about?

This clinical trial is focused on studying a condition known as Takotsubo syndrome, which is a temporary heart condition often triggered by stress. The study will evaluate the effectiveness of a medication called Cyclosporine A (also known as CsA) compared to a placebo. Cyclosporine A is a medication that is commonly used to prevent organ rejection after transplants and to treat certain inflammatory conditions.

The purpose of the study is to determine if Cyclosporine A can reduce heart muscle damage in patients with Takotsubo syndrome. Participants in the study will receive either Cyclosporine A or a placebo, in addition to their standard medical care. The study will monitor the levels of a specific protein in the blood, known as Troponin T, which is an indicator of heart muscle damage. This will help researchers understand if the treatment is effective in reducing damage to the heart.

Throughout the study, participants will undergo regular assessments to measure changes in their heart condition and overall health. These assessments will include monitoring Troponin T levels at various time points and evaluating heart function through imaging techniques. The study aims to provide valuable insights into the potential benefits of Cyclosporine A for patients with Takotsubo syndrome, with the hope of improving treatment options for this condition in the future.

1 joining the study

Participation begins after meeting specific criteria, including being over 18 years old and having a diagnosis related to Takotsubo syndrome.

Written consent is required before starting the trial.

2 initial treatment

Within 24 hours after a heart procedure called cardiac catheterization, the first dose of the study medication is administered.

The medication used is Cyclosporine A or a placebo, given as an intravenous bolus, which means it is injected directly into a vein in a concentrated form.

3 monitoring period

The primary focus is to measure heart damage using a specific blood test called high-sensitive Troponin T (TnT).

This test is conducted at several intervals: at the start, and then at 3, 12, 24, 36, 48, 60, and 72 hours after the initial treatment.

4 additional assessments

Other health indicators are monitored, including changes in heart function and any signs of heart inflammation or swelling.

These assessments may involve imaging tests and additional blood tests.

5 hospital stay

The length of stay in the hospital, including time in intensive care if needed, is recorded.

This information helps evaluate the overall impact of the treatment on recovery.

6 follow-up evaluations

Follow-up assessments occur at one month and one year after the initial treatment.

These evaluations include checking for any heart-related events and assessing quality of life.

Who Can Join the Study?

  • Patients must be over 18 years old.
  • Patients must be enrolled and receive the first dose of the study medication within 24 hours after a heart procedure called cardiac catheterization.
  • Patients must have a Regional Wall Motion Abnormality (WMA), which means a part of the heart is not moving normally, as seen in heart imaging tests like angiography or echocardiography.
  • Patients must have an InterTAK prognostic score of 16 or higher, or a GEIST Score of 20 or higher. These scores help predict the risk and severity of heart conditions.
  • Patients must have an InterTAK Diagnostic Score of 40 or higher. This score helps confirm the diagnosis of a specific heart condition.
  • Patients must provide written informed consent, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

  • Patients who are allergic to Cyclosporine A, a medication used to prevent organ rejection and treat certain inflammatory conditions.
  • Individuals with severe liver or kidney problems, as these organs are important for processing medications.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is consistently too high and not managed by treatment.
  • People with a history of certain heart conditions, such as heart attacks or heart failure, which affect how well the heart works.
  • Individuals who are pregnant or breastfeeding, as the effects of the medication on the baby are not known.
  • Patients currently participating in another clinical trial, to avoid interference with study results.
  • Individuals with certain infections, as these could worsen with the medication used in the trial.
  • People with a history of cancer, unless it has been in remission for a certain period, as the medication might affect cancer cells.
  • Patients with certain autoimmune diseases, where the immune system attacks the body, as the medication affects the immune system.
  • Individuals who have had a recent organ transplant, as their treatment might interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Herzzentrum Leipzig GmbH Leipzig Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Uxkoqlslhg Mmwqdmn Civeuf Hqmwsltoibhtuqqje Hamburg Germany
Umikpsxoexapqffbvthbp Evfel Azi Essen Germany
Mrsqznrjahsytoglxtfmhdcpgr Helmzdurixefpegd Halle (Saale) Germany
Uahoadpwlj Hjjjwlrj Cmnfblj Cologne Germany
Uuenczjvjwdsvpoilgmtl Dkomqigrboh Aaz Duesseldorf Germany
Gdtdql Ugephuzctb Fnfqbggmp Frankfurt Germany
Kthqqvru dfd Uoxpcagjzaqu Mqqyqpkj Aef Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.09.2024

Trial locations

Cyclosporine A (CsA) is a medication being tested in this clinical trial for its potential to reduce heart muscle damage in patients with Takotsubo syndrome. Takotsubo syndrome is a temporary heart condition often brought on by stress, and it can cause symptoms similar to a heart attack. The trial aims to see if Cyclosporine A can help protect the heart by reducing the amount of damage to the heart muscle, as measured by a specific blood test that tracks heart injury.

Investigated diseases:

Myocarditis – Myocarditis is an inflammation of the heart muscle, often caused by infections, autoimmune diseases, or exposure to certain toxins. The inflammation can lead to a reduction in the heart’s ability to pump blood effectively, potentially causing symptoms like chest pain, fatigue, and shortness of breath. Over time, the heart muscle may weaken, leading to complications such as heart failure or arrhythmias. The condition can vary in severity, with some individuals experiencing mild symptoms that resolve on their own, while others may develop more serious heart issues. The progression of myocarditis can be acute, occurring suddenly, or chronic, developing over a longer period. The exact cause of the inflammation often determines the course and severity of the disease.

Trial ID:
2024-511037-35-00
Protocol code:
CIT
NCT ID:
NCT05946772
Trial Phase:
Therapeutic exploratory (Phase II)

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