Ongoing Clinical Trials for Stress Cardiomyopathy
There are currently 4 clinical trials investigating different treatments for stress cardiomyopathy, also known as Takotsubo syndrome. These studies are testing medications that may help improve heart function and reduce complications in patients experiencing this stress-induced heart condition. The trials are being conducted across several European countries including Germany, Poland, Spain, and Scandinavia. (Also known as: Takotsubo syndrome, broken heart syndrome)
Clinical trial locations
- Denmark
- Germany
- Norway
- Poland
- Spain
- Sweden
Study of Levosimendan and Glucose Monohydrate for Patients with Low Ejection Fraction Takotsubo Syndrome
This trial is investigating whether levosimendan, a medication that helps the heart pump more effectively, can improve recovery in patients with Takotsubo syndrome who have severely reduced heart function.
Inclusion criteria: This study is for patients over 60 years old who are currently hospitalized with Takotsubo syndrome. To participate, your heart’s pumping ability must be 40% or less as measured by an ultrasound within 24 hours of hospital admission, or have decreased by 10% or more compared to previous values. You must also have a blood test showing NTproBNP levels of 500 pg/mL or higher, which indicates the heart is under stress.
Exclusion criteria: You cannot participate if you do not have Takotsubo syndrome, if your heart’s pumping ability is greater than 40%, or if you fall outside the specified age range. Individuals who are part of vulnerable populations requiring special protection may also be excluded.
Study focus: The trial aims to determine if levosimendan can speed up the recovery of heart function during hospitalization and reduce serious heart-related events such as heart failure, stroke, or recurrence of the syndrome over the following year. The medication is given through an intravenous infusion directly into the bloodstream. Participants will be monitored throughout their hospital stay and followed for 12 months after discharge.
Investigational drug: Levosimendan works by making the heart muscle more sensitive to calcium, which improves the heart’s ability to contract without significantly increasing oxygen demand. It is classified as a calcium sensitizer and inodilator.
Study on Beta-Blockers for Patients with Takotsubo Syndrome: Evaluating Selective, Non-Selective, and Alpha-Beta Blocking Agents
This Spanish trial is evaluating different types of beta-blockers to determine which works best for helping the heart recover in patients with Takotsubo syndrome.
Inclusion criteria: You must provide written informed consent and have a confirmed diagnosis of Takotsubo syndrome without significant blockage in the heart’s blood vessels, as confirmed by invasive angiography. Both men and women of various adult age groups can participate.
Exclusion criteria: You cannot participate if you have a different heart condition unrelated to Takotsubo syndrome, are currently in another clinical trial, have a history of severe allergic reactions to the study medications, are pregnant or breastfeeding, have a serious illness like advanced cancer, cannot follow study procedures, have a history of substance abuse, or have a mental health condition that interferes with understanding the study or giving consent.
Study focus: The trial will test three types of beta-blockers: selective ones like nebivolol and metoprolol, non-selective ones such as propranolol, and those with alpha activity like carvedilol. These oral medications slow the heart rate and reduce the heart’s workload, potentially helping it recover. The study will last up to 24 weeks, monitoring heart function improvements using echocardiography, which creates images of the heart using sound waves.
Investigational drugs: Beta-blockers work by blocking the effects of adrenaline on the heart, helping to reduce heart rate and blood pressure while decreasing the heart’s workload. Some types in this study have additional properties, such as alpha activity or nitric oxide release, which may provide extra benefits for heart function recovery.
Study on the Effects of Adenosine, Dipyridamole, and Apixaban in Patients with Takotsubo Syndrome
This multi-country Scandinavian trial is testing whether combining certain medications can improve outcomes and reduce the risk of blood clots in patients with Takotsubo syndrome.
Inclusion criteria: You must be 18 years or older, have a clinical diagnosis of Takotsubo syndrome with a heart pumping ability less than 50% at baseline, and provide written informed consent.
Exclusion criteria: You cannot participate if you have a history of Takotsubo syndrome, are outside the specified age range, are part of a vulnerable population, cannot follow study procedures or take study medications as required, or have any medical condition that would make participation unsafe.
Study focus: The trial has two parts. One examines whether combining adenosine, which helps regulate heart rhythm, with dipyridamole, which keeps blood vessels open, can improve outcomes compared to usual care. The other part tests whether apixaban, a blood-thinning medication, can reduce the risk of clot-related events like strokes or heart attacks. Participants will be randomly assigned to receive either the study medications or placebo and monitored for up to 30 days, with follow-up continuing for up to 10 years.
Investigational drugs: Adenosine is given intravenously and helps improve blood flow to the heart by binding to specific receptors. Dipyridamole is taken as an oral tablet and prolongs adenosine’s effects by preventing its reuptake into cells. Apixaban is an oral medication that prevents blood clots by inhibiting Factor Xa in the clotting process.
Study on the Effects of Cyclosporine A in Patients with Takotsubo Syndrome
This German trial is investigating whether Cyclosporine A, a medication commonly used to prevent organ rejection, can reduce heart muscle damage in patients with Takotsubo syndrome.
Inclusion criteria: You must be over 18 years old and receive the first dose within 24 hours after a cardiac catheterization procedure. You need to have abnormal heart wall motion visible on imaging tests, an InterTAK prognostic score of 16 or higher or GEIST Score of 20 or higher, and an InterTAK Diagnostic Score of 40 or higher. Written informed consent is required.
Exclusion criteria: You cannot participate if you are allergic to Cyclosporine A, have severe liver or kidney problems, uncontrolled high blood pressure, certain heart conditions like previous heart attacks or heart failure, are pregnant or breastfeeding, are in another clinical trial, have certain infections, have a history of cancer unless in remission for a certain period, have autoimmune diseases, or recently had an organ transplant.
Study focus: The trial will measure heart muscle damage using blood tests for Troponin T at multiple time points over 72 hours after treatment. Additional assessments will monitor heart function, inflammation, and swelling. Follow-up evaluations occur at one month and one year to check for heart-related events and assess quality of life.
Investigational drug: Cyclosporine A is given as an intravenous injection. It works by inhibiting calcineurin, which reduces the activity of immune cells called T-cells, potentially protecting the heart from further damage. It is classified as an immunosuppressant.
Summary
These four clinical trials represent diverse approaches to treating stress cardiomyopathy, with studies distributed across Europe including Poland, Spain, Germany, Sweden, Denmark, and Norway. The trials are testing different medication types: heart function enhancers like levosimendan, traditional heart medications like beta-blockers, blood flow regulators like adenosine and dipyridamole combined with blood thinners, and immunosuppressants like Cyclosporine A. This variety reflects ongoing efforts to find the most effective treatments for this stress-induced heart condition. Each study targets different aspects of the syndrome, from improving heart pumping ability to preventing complications like blood clots and reducing heart muscle damage. Patients interested in participating should consult with their healthcare providers to determine which trial might be appropriate for their specific situation.
