Ongoing Clinical Trials for Dilated Cardiomyopathy
Dilated cardiomyopathy is a heart condition where the heart muscle becomes weakened and enlarged, affecting its ability to pump blood effectively. Currently, there are 6 ongoing clinical trials testing different treatments for this condition, including gene therapy, medications that reduce inflammation, and cell-based treatments. These trials are being conducted across multiple countries in Europe, offering patients various opportunities to participate in research that may lead to new treatment options.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Romania
- Spain
- Study of AB-1002 gene therapy given through coronary arteries in adults with severe (NYHA Class III) heart failure caused by non-ischemic cardiomyopathy
- Study of Risedronate Sodium for Patients with Dilated Cardiomyopathy Due to Troponin T Gene Mutation
- Study on Early Use of Candesartan vs Placebo for People with Genetic Risk of Dilated Cardiomyopathy
- Study on Danicamtiv for Patients with Primary Dilated Cardiomyopathy Due to MYH7 or TTN Gene Variants
- Study on the Effectiveness of Autologous Bone Marrow Cells for Patients with Dilated Cardiomyopathy and Heart Failure
Study of AB-1002 gene therapy given through coronary arteries in adults with severe (NYHA Class III) heart failure caused by non-ischemic cardiomyopathy
This trial is testing a new gene therapy called AB-1002 for patients with severe heart failure caused by non-ischemic cardiomyopathy. The treatment is given as a single injection directly into the heart’s arteries and will be monitored for one year to see how well it works and whether it is safe.
Who can participate: Adults aged 18 to 65 years with chronic non-ischemic cardiomyopathy who have significant limitations in physical activity (NYHA Class III heart failure). Participants must have a left ventricular ejection fraction between 15% and 35%, be able to walk more than 50 meters in a six-minute test, and have been on stable heart failure medications for at least 30 days. Women of childbearing age must use effective birth control, and all sexually active participants must use barrier methods for 6 months after treatment.
Who cannot participate: People younger than 18 or older than 65, those with heart muscle disease caused by blocked arteries, people with Class I, II, or IV heart failure symptoms, anyone who has had a heart transplant or has a mechanical heart support device, and those with active infections, severe kidney or liver problems, uncontrolled high blood pressure, severe heart valve disease, cancer within the past 5 years, or blood clotting disorders.
What the trial involves: The study focuses on evaluating whether AB-1002 can improve heart function and exercise capacity in people with non-ischemic cardiomyopathy. The gene therapy is delivered through a procedure called intracoronary infusion, where the medication is administered directly into the blood vessels that supply the heart. Participants will undergo regular monitoring including heart ultrasounds, walking tests, blood tests, and quality of life assessments over the 52-week follow-up period.
Study of Risedronate Sodium for Patients with Dilated Cardiomyopathy Due to Troponin T Gene Mutation
This clinical trial is studying whether Risedronate, a medication usually taken as a 10 mg tablet, can improve heart function in patients who have dilated cardiomyopathy caused by a specific genetic change in the Troponin T gene (K210 deletion).
Who can participate: Adults older than 18 years who have dilated cardiomyopathy caused by the K210 deletion mutation in the Troponin T gene, with a left ventricular ejection fraction of 50% or less. Participants must provide written informed consent.
Who cannot participate: People who do not have dilated cardiomyopathy, those without the K210 deletion mutation in the Troponin T gene, and individuals outside the specified age range.
What the trial involves: Participants will take Risedronate daily for up to 12 months. The main goal is to see if the medication can improve the heart’s pumping ability, which will be measured using echocardiograms at the six-month mark. The study will also assess whether participants experience improvements in their ability to perform physical activities through stress tests that measure oxygen consumption.
Study on Anakinra for Treating Inflammatory Dilated Cardiomyopathy in Patients: Evaluating Efficacy and Safety of Anakinra with Standard Care vs. Standard Care Alone
This trial is testing a medication called Anakinra for treating inflammatory dilated cardiomyopathy, a condition where the heart becomes enlarged and inflamed, affecting its ability to pump blood effectively. The study will compare the effects of Anakinra combined with standard heart care to standard care alone.
Who can participate: Adults aged 18 to 75 years with a diagnosis of dilated cardiomyopathy who have symptoms that have not improved or have worsened despite at least 3 months of optimal therapy. Participants must have a left ventricular ejection fraction of less than 50% and increased levels of high-sensitive troponin T or signs of heart muscle inflammation on a cardiac MRI within the last 6 months. They must not have significant coronary artery narrowing and must be able to sign an informed consent form.
Who cannot participate: People with other heart conditions besides inflammatory dilated cardiomyopathy, those outside the age range of 18 to 65 years, pregnant or breastfeeding women, individuals with a history of severe allergic reactions to Anakinra, people with active or recurrent infections, those with cancer within the last 5 years (except certain skin cancers), anyone who has received another investigational drug within the last 30 days, and people with severe liver or kidney disease.
What the trial involves: The study will last for 12 weeks, during which participants will receive either Anakinra or a placebo through subcutaneous injection (under the skin), in addition to their usual heart treatment. Anakinra works by blocking a protein called interleukin-1, which is involved in causing inflammation. Throughout the study, participants will have regular check-ups to monitor their heart function using transthoracic echocardiography, which uses sound waves to create images of the heart and measure its pumping ability.
Study on Early Use of Candesartan vs Placebo for People with Genetic Risk of Dilated Cardiomyopathy
This trial is studying whether early treatment with Candesartan, a medication commonly used to treat high blood pressure and heart failure, can prevent changes in the heart that are associated with dilated cardiomyopathy in people who carry genetic variants that can cause the condition but do not yet show symptoms.
Who can participate: Adults aged 18 to 64 years who carry a genetic variant that can cause dilated cardiomyopathy, with a left ventricular ejection fraction of 50% or higher as measured by MRI. Blood tests must show a potassium level of 5.3 mEq/L or lower, creatinine level of 1.3 mg/dL or lower, and an estimated glomerular filtration rate of 60 ml/min/1.73 m² or higher. Participants must be able to understand the study requirements and provide informed consent.
Who cannot participate: People who are not genetic carriers of dilated cardiomyopathy causing variants, those who already show signs of the disease, individuals under 18 years old, pregnant or breastfeeding women, people with other serious health conditions that might interfere with the study, and those unable to follow study procedures.
What the trial involves: Participants will be randomly assigned to receive either Candesartan (8 mg or 16 mg tablets) or a placebo, taken orally once daily throughout the study period. The trial will monitor changes in the heart’s pumping ability (left ventricular ejection fraction) and the size of the heart’s main pumping chamber (left ventricular end-diastolic volume) over time using magnetic resonance imaging. The study aims to determine if early treatment with Candesartan can prevent or slow down changes in the heart that could lead to dilated cardiomyopathy. Candesartan works by helping to relax blood vessels, which can make it easier for the heart to pump blood and reduce the strain on the heart.
Study on Danicamtiv for Patients with Primary Dilated Cardiomyopathy Due to MYH7 or TTN Gene Variants
This trial is testing a new medication called Danicamtiv, taken as a tablet by mouth, for patients with primary dilated cardiomyopathy caused by genetic mutations in the MYH7 or TTN genes, or other causes. The study aims to explore the safety and initial effectiveness of this medication in improving heart function.
Who can participate: Adults aged 18 to 80 years who have been diagnosed with primary dilated cardiomyopathy due to specific genetic variants (MYH7 or TTN) or other causes. Participants must have a left ventricular ejection fraction between 15% and 45% and be on stable heart failure medication such as beta-blockers or ACE inhibitors (unless not tolerated). They must have a stable heart rhythm or controlled atrial fibrillation, be able to understand the study procedures and risks, and provide written consent. Men must use barrier methods of contraception, and women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control.
Who cannot participate: People with a history of severe allergic reactions to the study medication, those who have had a heart attack in the last 6 months, individuals with uncontrolled high blood pressure, severe liver or kidney disease, pregnant or breastfeeding women, people currently participating in another clinical trial, and anyone with other medical conditions that the study doctors think would make it unsafe to participate.
What the trial involves: Danicamtiv works by helping the heart muscle contract more strongly, which may improve the heart’s function. Participants will take the medication and be monitored regularly with various tests such as echocardiograms, blood tests, and physical examinations to assess the medication’s impact on heart health and to check for any side effects. The study will gather information on how well Danicamtiv is tolerated and its potential benefits for improving heart function in people with this specific genetic form of dilated cardiomyopathy.
Study on the Effectiveness of Autologous Bone Marrow Cells for Patients with Dilated Cardiomyopathy and Heart Failure
This trial is testing a treatment involving the use of autologous bone marrow-derived adult mononuclear cells for patients with idiopathic dilated cardiomyopathy. These are special cells taken from a patient’s own bone marrow and injected back into the heart through a method called intracoronary infusion, where the cells are delivered directly into the heart’s blood vessels.
Who can participate: Adults aged 18 to 70 years diagnosed with idiopathic dilated cardiomyopathy confirmed by echocardiogram for at least 6 months, with no signs of coronary artery blockages. Participants must have a left ventricular ejection fraction of less than 40%, or between 40% and 50% if left ventricular end-diastolic volume is greater than 110 ml/m². They must have been on stable medical treatment for at least 6 months, have a normal heartbeat pattern (sinus rhythm), and have normal laboratory test results. Women of childbearing age must have a negative pregnancy test and agree to use medically approved birth control during the study.
Who cannot participate: People with other types of heart disease (not idiopathic dilated cardiomyopathy), those who have had a recent heart attack or other serious heart events, individuals with severe kidney or liver disease, people with active infections or serious illnesses, pregnant or breastfeeding women, anyone who has participated in another clinical trial recently, and those unable to give informed consent.
What the trial involves: The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo. Throughout the study, participants will undergo various assessments to monitor changes in their heart function and overall health, including clinical evaluations, heart imaging tests such as echocardiograms, and exercise tests. The goal is to determine if this cell-based treatment can lead to better heart function and fewer heart-related problems over time.
Summary
These six ongoing clinical trials represent diverse approaches to treating dilated cardiomyopathy, ranging from advanced gene therapy and cell-based treatments to medications that target inflammation and genetic causes of the disease. Spain appears to be a particularly active center for research, hosting five of the six trials, while other trials are distributed across multiple European countries.
Several trials focus on specific genetic forms of the condition, such as those caused by mutations in the MYH7, TTN, or Troponin T genes, highlighting the growing emphasis on personalized medicine approaches. Other trials are exploring preventive strategies for people at genetic risk who have not yet developed symptoms, which could represent an important shift toward early intervention.
The treatments being tested include AB-1002 gene therapy, Risedronate, Anakinra for inflammatory forms, Candesartan for prevention, Danicamtiv for genetic forms, and autologous bone marrow cells. Each trial has specific eligibility criteria related to heart function measurements, age, and other health factors. Patients interested in participating should discuss these options with their cardiologist to determine which trial, if any, might be appropriate for their individual situation.
