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:

• People aged between 21 and 85 years old
• People who have been diagnosed with coronary artery disease (a significant blockage in at least one of the heart's main arteries), along with evidence of heart muscle damage, reduced heart pumping ability, and symptoms of heart failure
• People whose heart scans (MRI) show that at least 5% of the heart muscle has been damaged, including damage to the inner layer of the heart wall
• People whose heart pumping strength (called ejection fraction) is 40% or lower, as measured by MRI
• People who have been taking standard heart failure medications (such as beta blockers, water tablets, blood pressure medicines, or similar) at a stable, maximum tolerated dose for at least one month before joining the trial
• People with mild to moderate heart failure symptoms (classified as NYHA Class I, II, or III — confirm with trial site if unsure which class applies)
• Women who could become pregnant must be willing to use one form of birth control throughout the study and have a blood pregnancy test at the start and within 36 hours before receiving the study treatment

Who may not be able to join:

• People who need heart surgery (such as valve surgery, a heart pump device, or heart transplant), bypass surgery (CABG), or a coronary artery procedure (PCI) — although people who have already had CABG or PCI at least 3 months before joining may still be considered
• People who have had severe leaking or backflow through any heart valve in the past 12 months
• People who have had a stroke (either due to a blood clot or bleeding in the brain) within the past 90 days
• People who have a pacemaker or heart device (ICD) with certain limitations, such as being made before the year 2000, having leads placed less than 6 weeks ago, having certain types of leads or non-standard device setups, or any other feature that would make having an MRI unsafe (confirm specific device details with the trial site)
• People who are fully dependent on a pacemaker and also have an ICD implanted
• People who have had a cardiac resynchronization therapy (CRT) device placed less than 3 months before joining
• People who cannot safely have an MRI for any other reason, such as body size or other implants
• People whose ICD has delivered a shock or corrective pulse for a dangerous heart rhythm within the past 30 days
• People who have had a serious, prolonged irregular heart rhythm (ventricular tachycardia lasting 20 or more beats) without an ICD in the past 3 months, or a significant heart conduction problem without a working pacemaker in the past 3 months
• People with signs of active inflammation of the heart muscle (myocarditis)
• People with significantly reduced kidney function (eGFR below 35 ml/min/1.73m²)
• People with poorly controlled blood sugar levels (HbA1c above 10%)
• People with significantly low blood counts (low red blood cells, white blood cells, or platelets)
• People with significantly elevated liver enzyme levels (more than 3 times the normal upper limit)
• People with HIV, or active hepatitis B or hepatitis C infection
• People with a known severe allergic reaction (anaphylaxis) to penicillin or streptomycin
• People who have received a gene therapy or cell-based therapy in the past 12 months
• People with a history of cancer in the past 2 years (some skin cancers and cervical conditions that have been fully treated may be exceptions — confirm with trial site)
• People whose life expectancy is less than one year due to any condition
• People with a history of misuse of alcohol (5 or more drinks per day for more than 3 months) or illegal drugs, or documented problems caused by alcohol or drug use in the past 12 months
• People who have taken part in another clinical trial for a new treatment or device in the past 30 days
• People who are unable to give informed consent or complete study requirements due to language or cognitive barriers
• People who are pregnant, breastfeeding, or planning to become pregnant in the next 12 months
• People who have any other condition that, in the trial team's judgement, would affect their ability to safely participate (confirm with trial site)

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