Phase 2 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:

• Adults between 18 and 80 years old (inclusive) at the time of signing the consent form
• People who have been diagnosed with non-ischemic dilated cardiomyopathy (a type of weakened, enlarged heart not caused by blocked arteries) with a heart pumping function of 45% or less
• People who are already on recommended heart medications — at minimum, a beta blocker and at least one of certain blood pressure/heart failure medications (ACE inhibitors, ARBs, or ARNIs) — or who have a documented medical reason why one or both of these medications cannot be taken, and whose medication doses have been stable for at least 30 days before the procedure
• People who are considered suitable candidates for a heart catheterisation procedure
• People who are willing to undergo a DNA (genetic) test

Who may not be able to join:

• People who are eligible for, or need, standard surgical or non-surgical procedures to treat their non-ischemic dilated cardiomyopathy
• People with signs or a history of coronary artery disease (blockages in heart arteries), including chest pain with relevant test findings, a previous heart attack, prior stenting or bypass surgery, or evidence of scarring on a heart MRI suggesting undiagnosed blockages, or who need coronary artery procedures
• People with a documented blockage of 70% or more in one or more of the main heart arteries
• People with certain heart valve problems, including an artificial aortic valve, a mechanical mitral valve, a mitral valve clip, or severe aortic valve leakage within 12 months of signing consent (confirm with trial site)
• People with a narrowed aortic valve with an opening of 1.5 cm² or less (confirm with trial site)
• People whose cardiomyopathy is caused by a recent pregnancy (within 6 months), a specific structural heart condition called non-compaction (confirm with trial site), or a thickened heart muscle condition called hypertrophic cardiomyopathy (confirm with trial site)
• People whose cardiomyopathy is caused by a known toxic substance (such as amyloid protein deposits) — note: cardiomyopathy caused by certain chemotherapy drugs (anthracyclines) is allowed
• People with a specific abnormality on their heart electrical tracing (ECG) where the QTc interval — a measurement of a particular part of the heart's electrical cycle — is greater than 550 milliseconds
• People whose implanted heart defibrillator device has delivered a shock or rapid-pacing treatment for a dangerous heart rhythm in the 30 days before signing consent
• People whose kidney filtration rate falls below the minimum level set by the trial site
• People with certain abnormal blood test results at the start of the trial, including low red blood cell measures, low white blood cell count or more than twice the upper normal limit, or low platelet count
• People with liver problems, shown by liver enzyme levels (AST and ALT) more than three times the upper limit of normal
• People with blood clotting disorders, an INR (a blood clotting measure) above 1.5, people who cannot stop blood-thinning medication, or people who would refuse a blood transfusion
• People who have received a solid organ transplant (this does not exclude people who have had cell-based therapies more than 12 months before enrolment, or bone, skin, ligament, tendon, or corneal grafts)
• People with a history of rejecting a transplanted organ or cells
• People who have had a cancer diagnosis within the past 12 months — people with a prior cancer history must have been cancer-free for at least 12 months, except for certain treated skin cancers or treated cervical cancer
• People with drug and/or alcohol abuse or dependence within the past 9 months
• People who test positive for HIV, hepatitis B, or active hepatitis C
• People with a documented blood clot in the left ventricle of the heart, a tear in the main artery (aortic dissection), or an aortic aneurysm (confirm with trial site for left ventricular clot guidance)
• People with a long-term blood sugar level (HbA1c) above 10%
• People with a severe allergy to the contrast dye used in imaging procedures
• People with a known history of severe allergic reaction (anaphylaxis) to penicillin or streptomycin (certain antibiotics)
• People with a known sensitivity to a substance called dimethyl sulfoxide (DMSO)
• People with a non-heart condition where life expectancy is less than one year
• People who have had a stroke or mini-stroke (transient ischaemic attack) within 3 months of enrolment
• People who are pregnant, breastfeeding, or capable of becoming pregnant and not using effective contraception
• People who are fully dependent on a pacemaker and also have an implantable defibrillator (ICD) — note: people who are pacemaker-dependent but do not have an ICD are not excluded
• People who have a pacemaker and/or ICD with any of the following: the device was made before the year 2000; leads were implanted less than 6 weeks before signing consent; leads are placed outside the normal pathway or have been abandoned; a subcutaneous (under-the-skin) ICD; or a leadless pacemaker
• People who have had a cardiac resynchronisation therapy (CRT) device — a type of specialised pacemaker — implanted less than 3 months before signing consent
• People with other reasons they cannot have an MRI scan, such as body size incompatible with the scanner
• People who need advanced heart failure treatments such as medications given through a drip (IV inotropes)
• People who are currently enrolled in, or have participated within the last 30 days in, another trial of an investigational treatment or device
• People who, in the investigator's judgement, have any other condition that would make participation or follow-up unsafe or inappropriate

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