Phase 1 Cardiomyopathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 16 years and older but under 40 years old (for Phase 1A of the trial).
• People aged 4 years and older but under 16 years old (for Phase 1B of the trial).
• People in Phase 1A must be able to sign their own consent form.
• People who have been diagnosed with dilated cardiomyopathy (a condition where the heart is enlarged and cannot pump blood properly), which may include causes such as a heart defect present at birth, unknown causes, inherited or genetic causes, a history of heart muscle inflammation, exposure to chemotherapy or certain medications, infection, rheumatic disease, nutritional deficiencies, complications from Kawasaki disease or heart surgery, a specific pattern of irregular heart muscle (left ventricular noncompaction), or coronary artery disease.
• People whose heart pumping function (left ventricular ejection fraction) has been measured at 45% or below on an echocardiogram or cardiac MRI within the past six months.
• People whose left ventricle (the main pumping chamber of the heart) is enlarged, as measured by a specific score on an echocardiogram above +2.0.
• People whose heart has two functioning pumping chambers with the left ventricle acting as the main pumping chamber.
• People who are already receiving standard recommended treatments for heart failure, as outlined by major American heart health organisations.
• People who have not responded well to at least three months of these standard recommended treatments at the maximum doses.

Who may not be able to join:

• People who are listed for a heart transplant at the most urgent priority level, or who are currently hospitalised while waiting for a transplant and are on heart-supporting medications or devices.
• People who have had heart surgery or a procedure to treat a heart defect within the past three months, or who are expected to need corrective heart surgery within 12 months of joining the trial.
• People who have previously received a heart transplant.
• People who have a serious heart valve problem (affecting the aortic, pulmonary, mitral, or tricuspid valves) or a blockage in blood flow out of the heart or through the aorta, that is expected to need surgery or a procedure within six months.
• People diagnosed with a restrictive or hypertrophic cardiomyopathy (different types of heart muscle disease).
• People currently in cardiogenic shock (when the heart suddenly cannot pump enough blood to meet the body's needs).
• People currently being supported by a machine that takes over the work of the heart and lungs (extracorporeal membrane oxygenation, or ECMO).
• People currently using a mechanical device to help the heart pump (ventricular assist device).
• People with a life-threatening, uncontrolled heart rhythm problem that has caused unstable blood circulation and required emergency treatment such as defibrillation, continuous intravenous medications, or mechanical heart support.
• People with ongoing atrial fibrillation (an irregular heart rhythm) that requires specific medications to manage.
• People with a condition called amyloidosis (where abnormal proteins build up in organs).
• People whose heart failure is caused by blocked heart arteries (ischemic dilated cardiomyopathy).
• People who have had a cancer diagnosis within the past five years, except for certain skin cancers or cervical cancer that were fully treated and cured.
• People with a serious neurological condition, such as loss of vision, stroke, or paralysis.
• People with a severe blood clot in the lungs that required a catheter procedure to treat, or pulmonary hypertension (high blood pressure in the lung arteries) requiring certain medications.
• People with severely reduced kidney function (confirm with trial site for exact measurement details) or high potassium levels in the blood.
• People experiencing failure of multiple organs at the same time.
• People with a non-heart-related condition that is expected to limit life expectancy to less than one year.
• People with poorly controlled diabetes, based on a blood test result above a certain level at the time of screening.
• People with an active infection (including infection of the heart) that requires medication to treat.
• People currently experiencing sepsis (a severe, life-threatening response to infection).
• People with active bleeding, such as from the digestive tract or from an injury.
• People with a history of heart transplantation.
• People who are taking medications that affect or suppress the immune system at the time of enrolment or within the 12 weeks before joining.
• People whose cardiomyopathy is confirmed to be linked to a specific gene (dystrophin-associated) through standard genetic testing.
• People confirmed to have active myocarditis (heart muscle inflammation) at the time of screening.
• People with elevated liver enzyme levels (more than twice the normal upper limit) at the time of consent.
• People with elevated white blood cell counts above the normal range at the time of consent.
• People whose immune system has developed specific antibodies that would react against the treatment being studied.
• People with a history of not following medical advice, alcohol misuse, recreational drug use, or incarceration within the past year.
• People who are currently pregnant or breastfeeding.
• People whom the trial investigator considers it unsafe or not practical to enrol (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.