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:

• You must be between 18 and 80 years old at the time of screening
• You must have already tested positive for a specific genetic change called the R14 del PLN mutation
• Your heart's pumping ability (measured by an ultrasound of the heart) must show the heart is pumping out 45% or less of its blood with each beat
• Your heart failure symptoms must fall into a mild-to-moderate category (New York Heart Association class I, II, or III — confirm with trial site if unsure which applies to you)
• You must have been on a stable heart failure treatment plan for at least 6 weeks before screening, with no significant improvement during that time
• You must already have an implanted heart device — either a defibrillator (ICD) or a combined defibrillator and resynchronisation device (CRT-D)
• Your body mass index (BMI) must be between 18 and 35
• If you are a woman who could become pregnant, you must not be breastfeeding, and if you are sexually active with a male partner, you must agree to use a highly effective form of contraception
• All women must have a negative pregnancy test at the screening visit

Who may not be able to join:

• You have tested positive for Hepatitis C, Hepatitis B surface antigen, or Hepatitis B core antibody
• You have tested positive for HIV
• You have any other known genetic mutation linked to inherited heart rhythm or structural heart problems
• You have a condition called congenital long QT syndrome (an inherited heart rhythm disorder)
• Your heart's electrical reading (ECG) shows a specific measurement called QTcF below 350 milliseconds (confirm with trial site)
• You have, or have a family history of, a condition called Short QT syndrome
• You have a condition called catecholaminergic polymorphic ventricular tachycardia (a type of heart rhythm disorder), or have been hospitalised for heart failure or a serious irregular heartbeat within the past 3 months
• You have ongoing serious irregular heartbeats that need treatment and your doctor considers your condition unstable
• Scan results suggest you have had a previous heart attack and/or significant blockages or narrowing in the arteries supplying your heart, or you have had a procedure to open or bypass those arteries
• You regularly receive heart failure treatment through a drip (intravenous infusion) as an outpatient
• Your blood pressure is not well controlled
• You have significant problems with one or more of your heart valves
• You were born with a structural heart problem (congenital heart disease)
• The wall of your left heart chamber is thicker than 13mm, or a close relative has been diagnosed with hypertrophic cardiomyopathy (a thickening of the heart muscle)
• You have recently had an acute episode of myocarditis (inflammation of the heart muscle)
• You have a type of heart muscle disease linked to pregnancy (peripartum cardiomyopathy), a restrictive cardiomyopathy, or certain conditions that cause deposits to build up in the heart, such as sarcoidosis
• You drink alcohol in excess
• Your blood test results show that your liver enzymes, bilirubin, kidney function, or red blood cell levels fall outside the acceptable ranges for this trial (confirm specific values with trial site)
• Your blood pressure or heart rate at screening is above the acceptable limits for this trial (confirm specific values with trial site)
• Your heart condition is believed to have been caused by exposure to a toxic substance or a systemic disease
• You have a history of severe allergic reactions or have an ongoing significant allergy or hypersensitivity
• You have been exposed to a drug known to damage the heart, and this has caused heart muscle disease
• You have a non-heart-related illness that means your life expectancy is less than one year
• You have taken part in another clinical trial involving a study treatment within the last 3 months
• You have a known allergy or sensitivity to the study drug AZD4063
• You are currently taking part in a gene therapy trial

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