Ongoing Clinical Trials for Cardiomyopathy
Currently, 6 clinical trials are investigating new treatments for cardiomyopathy, a condition affecting the heart muscle. These studies are evaluating various medications and cell-based therapies to improve heart function, reduce inflammation, and prevent complications in patients with different forms of this heart disease. Trials are taking place across multiple European countries including Spain, Italy, Poland, Germany, France, and the Netherlands.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Spain
- Sweden
Study on Dapagliflozin to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy
This trial is testing whether dapagliflozin (brand name Forxiga) can prevent heart damage in breast cancer patients receiving anthracycline chemotherapy. The study focuses on patients with invasive breast cancer at stages I to III who are scheduled to begin this type of chemotherapy within 60 days.
Main inclusion criteria: Participants must be between 18 and 80 years old with a confirmed diagnosis of invasive breast cancer at stages I-III. They must have plans to start anthracycline treatment within 60 days and provide informed consent to participate.
Main exclusion criteria: The trial excludes patients with other types of cancer, those not in stage I-III of breast cancer, patients not planning anthracycline treatment within 60 days, those under 18 or over 65, patients with heart problems that could interfere with the study, pregnant or breastfeeding women, and those currently participating in another clinical trial.
Focus and goals: The study aims to determine if dapagliflozin can reduce the risk of heart dysfunction related to cancer treatment. Participants will be monitored for 12 months with regular assessments of heart function at 6 and 12 months, including measurements of heart-related biomarkers and changes in heart structure.
Investigational drug: Dapagliflozin is typically used to treat diabetes by helping the kidneys remove glucose from the bloodstream. In this trial, researchers are investigating whether it can also protect the heart from the harmful effects of chemotherapy. It works by inhibiting a protein called SGLT2 in the kidneys and may have protective effects on the heart. The medication is taken orally as a 10 mg tablet once daily for 12 months.
Study of Nucresiran in Adults with Transthyretin Amyloidosis with Cardiomyopathy to Evaluate its Effects on Survival and Heart Problems
This study is testing nucresiran in adults with transthyretin amyloidosis with cardiomyopathy, a condition where abnormal proteins build up in the heart muscle and affect its function. The trial will evaluate whether this medication can reduce deaths and heart-related medical events.
Main inclusion criteria: Participants must be between 18 and 85 years old with confirmed transthyretin amyloidosis with cardiomyopathy. They must have a history of heart failure with at least one previous hospitalization or clinical signs of heart failure. Patients must be clinically stable with no heart-related hospitalizations in the 6 weeks before starting the study. Their NT-proBNP blood test results must be between 300 and 8500 ng/L for most patients, or between 600 and 8500 ng/L for those with atrial fibrillation.
Main exclusion criteria: The trial excludes patients with a history of heart transplant or on a waiting list, severe liver disease, current treatment with tafamidis or other medications for ATTR amyloidosis, severe kidney disease requiring dialysis, blood clotting disorders, pregnant women or those planning pregnancy, active cancer or recent cancer treatment, uncontrolled high blood pressure, severe mental health conditions, recent drug or alcohol abuse, and life expectancy less than 2 years.
Focus and goals: The study aims to evaluate how well nucresiran works in reducing deaths and cardiovascular events in patients with this condition. Doctors will monitor heart health throughout the study, tracking heart-related hospitalizations, urgent care visits, and quality of life. The study will continue until June 2032.
Investigational drug: Nucresiran is given as an injection using a pre-filled syringe. It works by targeting and reducing the production of transthyretin protein that can build up in the heart tissue. The medication belongs to the class of RNA-targeting therapeutics and aims to reduce protein accumulation in the heart. Patients may continue taking their regular heart failure medications and other approved treatments while participating.
Study on Colchicine for Treating Patients with Inflammatory Cardiomyopathy
This trial is studying colchicine for treating patients with inflammatory cardiomyopathy, a condition involving inflammation of the heart muscle that can lead to irregular heartbeats and heart failure. The study will determine how effective colchicine is in improving patient health over six months.
Main inclusion criteria: Patients must be 18 years or older with evidence of heart muscle inflammation shown by cardiac MRI or FDG-PET imaging within the last 3 months. They must have at least one of the following conditions for more than 1 month: 3000 or more extra heartbeats in 24 hours, heart pumping function below 50% on echocardiogram or below 60% on cardiac MRI, elevated NT-proBNP levels of 1000 pg/mL or more, or continued elevated troponin levels with at least 1000 extra heartbeats in 24 hours.
Main exclusion criteria: Patients not diagnosed with inflammatory cardiomyopathy, those outside the specified age range, and those belonging to vulnerable populations cannot participate.
Focus and goals: The study aims to see if colchicine can help reduce inflammation and improve heart function in patients with this condition. Researchers will monitor various health indicators including heart imaging results and frequency of irregular heartbeats over the six-month treatment period. The study is single-blinded, meaning participants will not know whether they receive colchicine or placebo.
Investigational drug: Colchicine is an anti-inflammatory medication taken orally as a 1 mg tablet daily for 6 months. It works by disrupting the formation of microtubules, structures within cells that play a role in inflammation. The medication is thought to reduce inflammation in the heart muscle, potentially improving heart function and preventing further damage.
Study on the Effectiveness of Autologous Bone Marrow Cells for Patients with Dilated Cardiomyopathy and Heart Failure
This trial is testing a treatment using autologous bone marrow-derived adult mononuclear cells for patients with idiopathic dilated cardiomyopathy, a type of heart failure where the heart becomes enlarged and cannot pump blood efficiently. The cells are taken from the patient’s own bone marrow and injected directly into the heart’s blood vessels.
Main inclusion criteria: Patients must be between 18 and 70 years old with a diagnosis of idiopathic dilated cardiomyopathy confirmed by echocardiogram at least 6 months prior. Women of childbearing age must have a negative pregnancy test and use approved contraception. Patients must have no signs of coronary blockages shown by imaging tests and must have been on stable medical treatment for at least 6 months. Left ventricular ejection fraction must be less than 40%, or between 40% and 50% if the left ventricular volume is greater than 110 ml/m². Normal laboratory test results are required.
Main exclusion criteria: Patients with other types of heart disease beyond idiopathic dilated cardiomyopathy, recent heart attacks or serious heart events, severe kidney or liver disease, active infections or serious illnesses, pregnant or breastfeeding women, recent participation in another clinical trial, and those unable to give informed consent are excluded.
Focus and goals: The study aims to see if these bone marrow cells can help improve heart function in patients with this condition, for which there are currently no effective treatment options. Participants will undergo regular check-ups with physical examinations, blood tests, and heart imaging tests throughout the six-month treatment period. The study will assess changes in heart function and overall health, with completion expected by September 2025.
Investigational drug: The treatment involves intracoronary infusion of autologous bone marrow mononucleated cells taken from the patient’s own bone marrow. These cells are not expanded or grown in a lab before being injected back into the patient. The cells potentially aid in the repair and regeneration of heart tissue, falling under the category of regenerative medicine that focuses on using the body’s own cells to heal damaged tissues.
Study on the Effects of Mycophenolate Mofetil and Prednisolone in Patients with Chronic Virus-Negative Inflammatory Cardiomyopathy
This trial is studying the combination of mycophenolate mofetil (Mowel) and prednisolone for treating virus-negative inflammatory cardiomyopathy, a condition that affects the heart muscle and leads to decreased pumping ability. The study will evaluate whether this immunosuppressive treatment can improve heart function over 12 months.
Main inclusion criteria: Participants must be at least 18 years old and receiving medical treatment for heart failure for at least 3 months but not longer than 10 years. They must have a left ventricular ejection fraction less than 50% shown by echocardiogram within the last month. A heart biopsy must show signs of lymphocytic myocarditis with at least 14 white blood cells per square millimeter and increased expression of specific immune markers. The biopsy must not show established viral infection. Women of childbearing age must have a negative pregnancy test and use effective contraception.
Main exclusion criteria: Patients without virus-negative inflammatory cardiomyopathy, those whose heart function has not worsened despite optimal treatment, pregnant or breastfeeding women, patients with other interfering medical conditions, recent major surgery, known allergies to study medications, severe mental health conditions, drug or alcohol abuse within the past year, and life expectancy less than 2 years are excluded.
Focus and goals: The study aims to assess whether the combination treatment can lead to improvement in heart function over 12 months. Participants will be randomly assigned to receive either the active medications or placebo in a double-blind design. Heart function will be monitored using MRI scans and other tests at 6 and 12 months to evaluate changes in heart performance, exercise capacity, and quality of life.
Investigational drugs: Mycophenolate mofetil is an immunosuppressant that works by suppressing the immune system to reduce inflammation in the heart. It is administered orally as 500 mg film-coated tablets. Prednisolone is a corticosteroid that also reduces inflammation and suppresses the immune system. It is given orally in tablets of varying doses (1 mg, 5 mg, 10 mg, or 20 mg) as determined by the study team. Both medications aim to decrease immune activity and reduce heart inflammation, potentially improving heart function over time.
Study on the Effects of Zalunfiban for Patients with ST-Elevation Myocardial Infarction (Heart Attack)
This trial is studying zalunfiban for patients experiencing ST-elevation myocardial infarction (STEMI), a serious type of heart attack where part of the heart muscle is suddenly blocked from receiving blood. The study compares a single injection of zalunfiban with placebo to understand its safety and effectiveness.
Main inclusion criteria: Participants must be males aged 18 or older, or females who are post-menopausal or surgically sterile aged 50 or older. Weight must be between 52 and 130 kg. Patients must have documented presumed STEMI with persistent chest pain lasting more than 10 minutes and new ST-segment elevation of 2 mm or more in two adjacent ECG leads. The total time from symptoms to diagnostic ECG should be a maximum of 4 hours. Enrollment requires verbal or written informed consent from the patient or legally authorized representative.
Main exclusion criteria: The trial excludes patients who do not meet the specific criteria for STEMI with the required ECG changes and timing of symptoms.
Focus and goals: The study aims to assess patient outcomes 30 days after receiving treatment, monitoring for major health events such as death, stroke, or another heart attack, as well as bleeding incidents. The medication is administered as a single injection under the skin before the patient reaches the hospital. The research seeks to understand how zalunfiban might improve outcomes when given early during a heart attack.
Investigational drug: Zalunfiban is given as a single subcutaneous injection and is being studied to determine its safety and effectiveness for STEMI patients. It works by blocking certain proteins in the blood that can cause blood clots, helping to keep blood flowing smoothly to the heart. Zalunfiban is classified as an antiplatelet medication that helps prevent blood cells called platelets from sticking together and forming clots. Throughout the study, patients will be monitored for 30 days to assess the treatment’s impact and any potential side effects.
Summary
The six ongoing clinical trials for cardiomyopathy reflect diverse approaches to treating different forms of this heart condition. A notable concentration of research is taking place across Western European countries, with Spain, Italy, France, Germany, and the Netherlands hosting multiple trials. The largest multi-country trial is the nucresiran study for transthyretin amyloidosis with cardiomyopathy, which spans 11 European countries.
The trials demonstrate varied therapeutic strategies, from traditional medications like colchicine and immunosuppressive therapies to innovative approaches including cell-based regenerative medicine and novel RNA-targeting therapeutics. Several studies focus on inflammatory forms of the condition, while others address prevention of chemotherapy-induced heart damage and acute heart attack complications. Treatment durations range from single-dose emergency interventions to 12-month monitoring periods, reflecting the different nature and goals of each investigation.
Most trials employ randomized, placebo-controlled designs to ensure reliable results, with careful monitoring of heart function through imaging techniques and biomarker assessments. The research addresses both rare genetic forms of cardiomyopathy and more common inflammatory conditions, offering hope for improved treatment options across the spectrum of heart muscle diseases.
