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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

10 criteria

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.

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Verified sites

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Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Goethe University Frankfurt
Frankfurt, Germany

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Cyclosporine A – This medication is administered intravenously and is currently being studied in a clinical trial for its potential benefits in patients with Takotsubo syndrome. Cyclosporine A is well-established in medical literature for preventing organ rejection after transplants and treating inflammatory conditions like myocarditis. It works by inhibiting calcineurin, which reduces the activity of T-cells, a type of immune cell. This places it in the pharmacological class of immunosuppressants.

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.