Cardiomyopathy Trial, Recruiting

Written by an AI model from the 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 diagnosed with idiopathic dilated cardiomyopathy (a type of heart disease where the heart muscle is weakened for no known reason) who still have significant symptoms despite receiving proper heart failure treatment, classified as NYHA class III or IV (meaning moderate to severe limitations in daily activity).
• People diagnosed with non-ischaemic cardiomyopathy (a weakened heart not caused by blocked arteries) who still have significant symptoms despite receiving proper heart failure treatment, classified as NYHA class III or IV.
• People whose heart pumping strength, measured by a specific test called ejection fraction, falls within certain ranges — either between 25% and 35% (for the first group) or between 40% and 50% (for the second group), as confirmed by a central testing laboratory.
• People who have had chronic heart failure symptoms for more than one year but less than five years at the time of screening, based on their official diagnosis date.
• People aged 18 to 75 years.
• People who are able to understand what the treatment involves, are willing to take part in a six-month treatment period, understand that the device may be removed afterward, are aware of possible risks, and are able to give written consent and attend all required follow-up visits.
• People who have been on a stable, guideline-recommended heart failure medication plan for at least three months before screening, where "stable" means the dose has not changed by more than 50% up or down (with documented evidence if certain medications are not tolerated).
• People able to complete an unassisted six-minute walk test.
• People with a body mass index (BMI) between 20 and 36 kg/m².

Who may not be able to join:

• People whose heart failure has a treatable underlying cause, such as a heart valve problem or a heart condition present from birth.
• People who, according to current medical guidelines, are recommended to receive a cardiac resynchronisation therapy (CRT) device.
• People who were hospitalised for heart failure and needed strong heart-stimulating medications (inotropes) within the 30 days before screening.
• People with high blood pressure readings above 150/90 mmHg even while on optimal blood pressure medication.
• People with low haemoglobin (a measure of red blood cells) — below 12 g/dL for males or below 10 g/dL for females.
• People with a condition called primary pulmonary hypertension (high blood pressure in the lungs not caused by another illness).
• People with a genetic connective tissue disorder, such as Marfan syndrome.
• People who have an artificial tricuspid heart valve.
• People where the leads (wires) needed for the device cannot be placed, for example due to a blocked vein or previous radiation treatment to the chest area.
• People with physical features, such as chest wall deformity, that the investigator believes would make device placement difficult (confirm with trial site).
• People who already have an implanted pacemaker, defibrillator (ICD), CRT device, or CCM device.
• People who are currently pregnant.
• People who are currently breastfeeding.
• Women who are capable of becoming pregnant and are not using a highly effective method of contraception starting two months before and continuing until one month after the treatment period (confirm with trial site for what methods are considered acceptable).
• People whose limited ability to exercise is caused by a condition other than heart failure, such as a chronic lung condition or circulation problems in the legs.
• People currently taking immunosuppressive medications (drugs that reduce the immune system's activity).
• People with an active cancer diagnosis.
• People with an active infection that the investigator considers unsafe for study participation.
• People with significantly reduced kidney function, specifically an estimated kidney filtration rate below 45 mL/min/1.73m² (confirm with trial site).
• People with significant liver disease or abnormal liver function test results at the time of screening, unless the abnormality is clearly caused by the heart condition alone and no other liver damage is present.
• People with a history of drug or alcohol misuse in the 12 months before screening.
• People who, in the investigator's opinion, are unlikely to follow the study requirements, attend follow-up visits, or complete the trial.
• People who have taken part in another clinical trial of an investigational device or drug within 90 days before this study.
• People considered vulnerable, including those who require a legal guardian to make decisions, people held in detention, people currently serving in the military, or employees of the study sponsor or trial site.
• People who cannot avoid environments with strong magnetic fields, strong external electrical interference, high temperatures, or areas that display warnings prohibiting entry for pacemaker patients.

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