Phase 4 Heart Disease 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 who have given written consent to take part in the study, including agreeing to two heart tissue biopsies and two heart MRI scans.
• People who have been clinically suspected of having, or already diagnosed with, myocarditis (inflammation of the heart muscle) or inflammatory cardiomyopathy (an inflammatory condition affecting the heart), based on specific medical guidelines — or who have had a confirming heart tissue biopsy within the past 3 months under this study's protocol.
• Men or women aged 18 to 65, where women of childbearing potential must have a negative pregnancy test and must be using a highly reliable form of contraception (or be confirmed post-menopausal or surgically sterile) for the duration of the study and for 8 weeks after the last dose of study treatment.
• People whose condition has not meaningfully improved, or has worsened, despite standard treatment over at least the 3 months before screening, in the treating doctor's opinion.
• People whose heart pumping function (measured as "left ventricular ejection fraction" or LVEF) is between 10% and 45% on an echocardiogram (heart ultrasound) taken during the screening period, with no significant improvement over the prior 3 months in the treating doctor's opinion, measured under stable conditions and confirmed by a central laboratory.
• People whose heart tissue biopsy (taken during screening or within the past 3 months) shows active myocarditis or inflammatory cardiomyopathy under laboratory analysis.
• People whose heart tissue biopsy (taken during screening or within the past 3 months) shows no heart-affecting viruses detected by PCR testing.

Who may not be able to join:

• People who have medical reasons why they cannot safely take immunosuppressive medicines such as steroids or azathioprine — including known allergy to these medicines, untreated serious infection, uncontrolled diabetes, poorly controlled hormonal conditions, osteoporosis, active stomach or intestinal ulcers, uncontrolled high blood pressure, or certain low blood cell counts (confirm with trial site for specific thresholds).
• People who test positive for active infections including HIV, hepatitis B, or hepatitis C, or who may have active tuberculosis (the treating doctor will assess tuberculosis risk based on local conditions; in some cases participation may continue after careful evaluation).
• People whose heart failure is explained by another specific cause, such as severe congenital heart disease, significant valve disease, high blood pressure-related heart disease, or significant coronary artery disease.
• People whose heart muscle disease is caused by conditions such as amyloidosis, haemochromatosis, Fabry disease, muscular dystrophy, genetic hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, or known pericardial constriction.
• People with diagnosed or suspected cardiac sarcoidosis, giant cell myocarditis, or certain autoimmune or immune-related diseases that require their own specific immunosuppressive treatment — or people who are currently on, recently were on, or are expected to need long-term immunosuppressive therapy (note: short-term steroid use, such as for an asthma episode or occasional topical use, is not an automatic exclusion).
• People whose heart failure symptoms are classified as either NYHA Class I (no symptoms) or NYHA Class IV (severe symptoms at rest) (confirm with trial site).
• People with a body mass index (BMI) above 40, or who weigh less than 50 kg.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial, or who are unwilling to use effective contraception.
• People with a current or past cancer diagnosis within the 5 years before screening, or any suspected active cancer.
• People with a history of chemotherapy or radiation therapy.
• People with liver disease, indicated by certain elevated liver enzyme levels or bilirubin in blood tests (confirm with trial site for specific values).
• People with significantly reduced kidney function (below a certain threshold on a kidney function test), or who are on dialysis — though the treating doctor may consider including people whose kidney function is just at the borderline (confirm with trial site).
• People who are taking a medication that could interfere with the study and are unwilling or unable to stop it (for example, allopurinol).
• People who currently have, or are planned to receive, a ventricular assist device (a mechanical heart pump), cardiac resynchronisation therapy (a type of pacemaker), or a heart transplant.
• People with a pacemaker or implantable defibrillator that requires the device to pace the heart more than 30% of the time, which in the treating doctor's opinion could affect heart function measurements.
• People who have had gastrointestinal surgery or have a bowel condition that, in the treating doctor's opinion, could affect how the study medications are absorbed.
• People with another illness where life expectancy is less than 3 years.
• People who have certain contraindications to heart MRI (cardiac MRI/CMR), including: a cardiac electronic device implanted less than 6 weeks ago; abnormal pacing thresholds; certain additional or abandoned heart leads or device components; certain metal implants in the body, eyes, or skin; claustrophobia that would make it impossible to complete the MRI; or any other condition that the treating doctor judges could make the MRI unsafe.
• People who have received a live vaccine within the 3 months before being randomly assigned to a treatment group.
• People with a history of chronic alcohol or drug misuse, who are unlikely to follow medical recommendations, or who in the treating doctor's opinion are unlikely to reliably complete the trial.
• People who are currently taking part in another clinical drug trial, or who have done so within 30 days before enrolling (or within 5 half-lives of the other drug, whichever is longer).
• People who are directly involved in running this study.

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