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Ongoing Clinical Trials Related to Cardiac Disorder

This article provides detailed information about 12 ongoing clinical trials investigating various treatments for cardiac disorder and related conditions. These trials are being conducted across multiple European countries and involve medications such as NTLA-2001, acalabrutinib, pelacarsen, semaglutide, methylprednisolone, cefazolin, isoflurane, metformin, vutrisiran, dobutamine, tocilizumab, and FDY-5301, as well as studies on opioid medications before surgery.

Clinical trial locations

Study of NTLA-2001 for Patients with Transthyretin Amyloidosis and Heart Disease

This trial is testing NTLA-2001, a gene therapy medication, in patients with transthyretin amyloidosis with cardiomyopathy. This condition involves abnormal protein buildup in the heart, which leads to heart problems and can progress to severe complications over time.

Inclusion criteria: To participate, you must be between 18 and 90 years old and have a confirmed diagnosis of ATTR amyloidosis with cardiomyopathy. You should have a history of heart failure with symptoms that are well-managed and stable for at least 28 days. A blood test showing NT-proBNP levels of at least 1000 pg/mL is required, or 2000 pg/mL if you have atrial fibrillation.

Exclusion criteria: You cannot participate if you have other serious health conditions that could interfere with the study, are currently in another clinical trial, have had a recent heart attack or stroke, have severe allergic reactions, are pregnant or breastfeeding, have a history of drug or alcohol abuse, have an active infection requiring antibiotics, have had cancer within the last five years, have an immune system condition, or have had major surgery within the last three months.

Study focus: The trial aims to assess whether NTLA-2001 can reduce heart-related deaths and events in patients with this condition. The medication is administered intravenously and uses CRISPR technology to target and reduce the production of abnormal transthyretin protein. Researchers will monitor heart health markers, including serum transthyretin levels, and assess quality of life throughout the study.

Investigational drug: NTLA-2001 is an experimental gene-editing therapy delivered through intravenous infusion. It works by editing genes to decrease abnormal protein production that damages the heart.

Study on Acalabrutinib for Adults with Chronic Lymphocytic Leukemia and Heart Issues

This trial evaluates acalabrutinib for adults with chronic lymphocytic leukemia who also have moderate to severe heart problems. The study compares acalabrutinib used alone with other treatments selected by doctors.

Inclusion criteria: Participants must be 18 years or older with an ECOG performance status of 0 to 3, have a left ventricular ejection fraction less than 50%, and have a confirmed diagnosis of chronic lymphocytic leukemia. You must be either treatment-naïve or have received no more than two prior treatments. Active disease requiring treatment is necessary, and specific laboratory values must be met, including adequate blood counts, liver and kidney function. Participants must use effective contraception and be willing to follow study requirements.

Exclusion criteria: You cannot participate if you have other serious health conditions, a history of different cancers unless cured, are pregnant or breastfeeding, have an active infection, have had a heart attack or stroke in the last six months, are in another trial, have an allergy to the study medication, have a history of substance abuse, have a mental health condition affecting participation, or have had major surgery in the last four weeks.

Study focus: The trial aims to evaluate the safety and tolerability of acalabrutinib over 72 weeks, monitoring the need for additional heart procedures and tracking heart-related deaths, overall mortality, non-fatal heart attacks, and strokes.

Investigational drug: Acalabrutinib is taken orally in tablet form and works by inhibiting Bruton’s tyrosine kinase, an enzyme important for cancer cell growth. It is classified as a targeted therapy specifically designed for chronic lymphocytic leukemia patients with heart impairment.

Study on Pelacarsen for Slowing Calcific Aortic Valve Stenosis in Patients

This study tests pelacarsen in patients with calcific aortic valve stenosis, a condition where calcium buildup narrows the heart’s aortic valve, making it harder for the heart to pump blood.

Inclusion criteria: Participants must be between 50 and 79 years old with lipoprotein(a) levels of 175 nmol/L or higher. You should have mild or moderate calcific aortic valve stenosis, measured by a peak aortic jet velocity between 2.5 and 3.5 meters per second. At enrollment, you must be receiving optimal treatment for cardiovascular risk factors like LDL cholesterol, diabetes, and high blood pressure.

Exclusion criteria: You cannot participate if you have severe allergic reactions to the medication, other serious heart conditions, have had a heart attack or stroke in the past six months, have uncontrolled high blood pressure, severe kidney or liver disease, are pregnant or breastfeeding, are in another trial, have a history of substance abuse in the past year, or have any condition that makes participation unsafe.

Study focus: The trial evaluates whether pelacarsen can slow the progression of calcific aortic valve stenosis over 36 months. The medication is administered through subcutaneous injections, and researchers will monitor changes in heart valve function and calcium deposits using echocardiography and CT imaging.

Investigational drug: Pelacarsen is an antisense oligonucleotide that works by lowering lipoprotein(a) levels in the blood. It is injected under the skin and aims to reduce the protein linked to disease progression.

Study on Semaglutide for Achieving Sinus Rhythm in Patients with Obesity and Persistent Atrial Fibrillation

This trial investigates semaglutide’s effects on individuals with atrial fibrillation and obesity, aiming to restore normal heart rhythm after electrical cardioversion.

Inclusion criteria: You must have symptomatic, first detected persistent atrial fibrillation noticed no more than six months before joining, be 18 years or older, have a BMI of 30 or higher (or 27 or higher with weight-related health issues like high blood pressure or cholesterol), be scheduled for electrical cardioversion, and provide written informed consent.

Exclusion criteria: You cannot participate if you do not have obesity, do not have atrial fibrillation, have not experienced symptomatic persistent atrial fibrillation, are not within the specified age range, or are part of a vulnerable population.

Study focus: The trial assesses whether weekly semaglutide injections over one year can help achieve and maintain normal heart rhythm. Researchers will monitor atrial fibrillation symptoms, quality of life, weight changes, hospital visits, blood pressure, and cholesterol levels.

Investigational drug: Semaglutide is administered as a once-weekly subcutaneous injection at a dose of 2.4 mg. It is a GLP-1 receptor agonist that helps regulate appetite and insulin levels, aiding in weight loss and potentially improving heart function.

Evaluation of Methylprednisolone and Prednisone in Adult Patients with Acute Myocarditis and Reduced Heart Function

This study focuses on acute myocarditis, where heart muscle inflammation leads to reduced function. The trial tests whether corticosteroid treatment with methylprednisolone and prednisone can improve heart function and prevent complications.

Inclusion criteria: Participants must be at least 18 years old, enrolled in the French healthcare system, and have active myocarditis confirmed by symptoms such as chest pain or heart failure, elevated troponin levels, and confirmation through cardiac imaging or tissue analysis. You must have reduced heart function with a left ventricular ejection fraction less than 50% or abnormal heart muscle movement. Normal heart arteries confirmed by examination or CT scan are required.

Exclusion criteria: You cannot participate if you are below 18 or above 65 years old, have a previous history of heart failure, are pregnant or breastfeeding, have allergies to the study medications, have active infections, have autoimmune diseases, have had a heart attack in the past 30 days, cannot undergo cardiac magnetic resonance imaging, are in other trials, have severe kidney or liver disease, have uncontrolled diabetes, have a history of chronic steroid use, have mental conditions affecting consent, have active cancer, or cannot take oral medications.

Study focus: The trial evaluates whether corticosteroid treatment can improve heart function over six months. Participants receive intravenous methylprednisolone for three days followed by oral prednisone tablets, while continuing standard heart failure therapy.

Investigational drugs: Methylprednisolone is given intravenously for three days, followed by oral prednisone tablets. Both are glucocorticoids that reduce inflammation and suppress immune responses in heart tissue.

Study on How Albumin Levels Affect Cefazolin in Heart Disease Patients with Low Albumin Undergoing Cardiac Surgery

This trial examines how low albumin levels in the blood affect the way the body processes cefazolin, an antibiotic used to prevent infections during heart surgery.

Inclusion criteria: Participants must provide written informed consent, be between 18 and 90 years old, have planned use of cardiopulmonary bypass during surgery, and have an ejection fraction greater than 40%.

Exclusion criteria: You cannot participate if you have heart disease or hypoalbuminemia, conditions this study specifically investigates.

Study focus: The trial studies how albumin levels influence cefazolin processing in patients undergoing heart surgery. Participants are randomly assigned to receive either human albumin infusion or not, and researchers monitor cefazolin concentrations in the blood over 10 hours.

Investigational drug: Cefazolin is a cephalosporin antibiotic given intravenously at 2 grams. It works by interfering with bacterial cell wall formation, preventing bacterial growth and infection during surgery.

Study on Isoflurane, Propofol, and Dobutamine Hydrochloride for Sedation in Adults with Severe Cardiogenic Shock on ECMO

This trial investigates sedation with inhaled isoflurane for patients with severe cardiogenic shock supported by venoarterial extracorporeal membrane oxygenation.

Inclusion criteria: Participants must be adults with severe cardiogenic shock on VA-ECMO support for less than 24 hours, on invasive mechanical ventilation for less than 48 hours, receiving propofol and/or midazolam, expected to need mechanical ventilation and sedation for at least 24 hours with a Richmond agitation scale target of -1 to -4, and have social security registration.

Exclusion criteria: You cannot participate if you have been on VA-ECMO for more than 24 hours, are not an adult, are not experiencing severe cardiogenic shock, cannot use the inhaled medication, or are part of a vulnerable population.

Study focus: The trial assesses whether inhaled isoflurane can improve survival rates and increase ventilator-free days within 28 days of ECMO support. Researchers will monitor the need for heart transplants, additional support devices, and days free from ECMO, inotropes, and intensive care.

Investigational drug: Isoflurane is administered as an inhaled gas through a device that conserves anesthetic for patients on mechanical ventilation. It works by affecting brain neurotransmitters to maintain sedation and is classified as a general anesthetic.

Study on Metformin’s Effect in Reducing Unplanned Heart Procedures in Non-Diabetic Patients with Acute Coronary Syndrome

This trial evaluates whether metformin can reduce the need for additional unplanned procedures to restore blood flow to the heart in non-diabetic patients who have undergone percutaneous coronary intervention due to acute coronary syndrome.

Inclusion criteria: Participants must be older than 18 years, have experienced their first episode of acute coronary syndrome treated with percutaneous coronary intervention using a drug-eluting stent, live close enough to the study site for monitoring, have an uncomplicated disease course, have no history of diabetes, have not taken hypoglycemic drugs in the last six months, have HbA1c levels less than 6.5% during hospitalization, and provide written consent.

Exclusion criteria: You cannot participate if you have diabetes, have not undergone percutaneous coronary angioplasty, are not experiencing acute coronary syndrome, are under 18 years old, or are part of a vulnerable population.

Study focus: The trial monitors participants over 30 months to assess whether metformin reduces unplanned coronary revascularization and tracks cardiac death, death from any cause, non-fatal heart attacks, and non-fatal strokes.

Investigational drug: Metformin is taken orally in tablet form and works by decreasing glucose production in the liver and improving insulin sensitivity, which may benefit cardiovascular health. It is classified as a biguanide.

Study of Vutrisiran for Patients with Transthyretin Amyloidosis and Heart Disease

This trial tests vutrisiran, an RNA interference therapeutic, in patients with transthyretin amyloidosis with cardiomyopathy. The condition involves abnormal protein deposits that cause the heart to become stiff and less effective at pumping blood.

Inclusion criteria: Participants must be between 18 and 85 years old, agree to sign medical record release forms, have a confirmed diagnosis of ATTR amyloidosis with cardiomyopathy, have a history of heart failure with at least one previous hospitalization or signs requiring diuretic treatment, meet specific conditions regarding tafamidis use, be in stable health with no heart-related hospitalizations in the last six weeks, have NT-proBNP levels between specified ranges, be able to walk at least 150 meters during a 6-minute walk test, have a Karnofsky performance status of 60% or higher, and provide written informed consent.

Exclusion criteria: You cannot participate if you have a different type of amyloidosis, are not within the specified age range, cannot follow study procedures or take medication as required, have other serious health conditions, are pregnant or breastfeeding, have participated in another trial recently, have a history of substance abuse, or have allergies to the study medication.

Study focus: The trial evaluates whether vutrisiran can reduce deaths from any cause and cardiovascular events compared to placebo. Researchers will also assess walking ability, quality of life, and overall health status through regular check-ups over the study period.

Investigational drug: Vutrisiran is administered via subcutaneous injection at 25 mg in a pre-filled syringe. It uses small RNA molecules to reduce transthyretin protein production, thereby slowing disease progression.

Study on Dobutamine and Tocilizumab for Patients with Heart Attack at High Risk of Cardiogenic Shock

This trial investigates dobutamine and tocilizumab in patients who have experienced a heart attack and are at high risk of developing cardiogenic shock, a condition where the heart cannot pump enough blood to meet the body’s needs.

Inclusion criteria: Participants must have had an acute myocardial infarction, undergone revascularization with percutaneous coronary intervention, experienced chest pain within 24 hours of seeking medical attention, have an ORBI risk score of 11 or higher, and be 18 years or older.

Exclusion criteria: You cannot participate if you had a heart attack more than 24 hours ago, are already in cardiogenic shock when arriving at the hospital, are not at intermediate to high risk of developing cardiogenic shock, are not within the specified age range, cannot give informed consent, have other interfering medical conditions, are pregnant or breastfeeding, or are in another trial simultaneously.

Study focus: The trial evaluates whether these medications can affect blood markers indicating heart function and stability. Researchers monitor NTproBNP levels up to 48 hours after admission, assess infarct size using cardiac MRI, evaluate biomarkers related to heart function and inflammation, and perform echocardiographic measurements. Long-term outcomes such as mortality, re-admission rates, and quality of life are assessed over one year.

Investigational drugs: Dobutamine is given as a low-dose intravenous infusion to support heart function by helping the heart pump more effectively. It stimulates beta-1 adrenergic receptors in the heart, increasing heart rate and contraction strength. Tocilizumab is given as a single intravenous dose to reduce inflammation by blocking the interleukin-6 receptor, potentially stabilizing heart function.

Study on the Effects of FDY-5301 for Patients with Anterior ST-Elevation Myocardial Infarction (Heart Attack)

This trial studies FDY-5301, a solution for injection containing sodium iodide, in patients with anterior ST-elevation myocardial infarction, a specific type of heart attack affecting the front part of the heart.

Inclusion criteria: Participants must be at least 18 years old and have an anterior STEMI confirmed by symptoms such as chest pain, shortness of breath, jaw pain, arm pain, or sweating, as well as electrocardiogram findings.

Exclusion criteria: You cannot participate if you have had a heart attack that is not an anterior STEMI, are not undergoing primary percutaneous coronary intervention, are outside the specified age range, are not part of the specified trial groups, or are considered part of a vulnerable population.

Study focus: The trial aims to determine if FDY-5301 can reduce heart-related deaths and prevent heart failure events over 12 months. Researchers will monitor for heart-related complications, measure troponin T levels on the third day after treatment, and assess overall heart function.

Investigational drug: FDY-5301 is an experimental medication given through intravenous infusion. It is currently in the experimental phase, with ongoing research to determine its effectiveness in patients undergoing primary percutaneous coronary intervention for anterior STEMI.

Summary

These 12 ongoing clinical trials reflect a diverse range of research approaches to treating various heart conditions and related disorders. The trials are spread across multiple European countries, with particularly strong representation in countries such as Italy, Germany, Spain, France, Poland, Czechia, Netherlands, Portugal, Belgium, Austria, Denmark, Sweden, Norway, and Hungary.

Several trials focus on transthyretin amyloidosis with cardiomyopathy, a condition where abnormal protein deposits affect heart function. Two major studies investigate gene therapy and RNA interference approaches with NTLA-2001 and vutrisiran, representing cutting-edge treatment strategies. Other notable areas of research include calcific aortic valve stenosis, acute myocardial infarction, cardiogenic shock, atrial fibrillation, and myocarditis.

The investigational drugs span various mechanisms of action, from gene-editing therapies and RNA interference to traditional corticosteroids, antibiotics, and opioids. Several trials employ advanced imaging techniques such as cardiac MRI and echocardiography to monitor treatment effectiveness and disease progression.

These studies demonstrate the ongoing effort to develop new treatment approaches for serious cardiovascular conditions, with an emphasis on improving survival rates, preventing complications, and enhancing quality of life for patients with heart disease.

Ongoing Clinical Trials on Cardiac disorder

  • Study on Dobutamine and Tocilizumab for Patients with Heart Attack at High Risk of Cardiogenic Shock

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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