Phase 3 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:

• Adults aged 18 or older
• People who have had a confirmed heart failure diagnosis for more than 12 months, whether caused by a blocked blood supply to the heart or another cause
• People whose heart was previously pumping weakly (with a pumping strength of 45% or less), but whose heart pumping has since returned to a normal level (50% or more) for at least the past 6 months, as confirmed by a heart ultrasound
• People whose heart size (left ventricle volume relative to body size) is within the normal range — up to 74ml/m² for men and 61ml/m² for women (confirm with trial site)
• People with no symptoms or only mild symptoms of heart failure (able to do everyday activities without significant limitation)
• People who have not been admitted to hospital for heart failure in the past six months
• People who have been taking a beta-blocker medication specifically for heart failure (bisoprolol, carvedilol, metoprolol, or nebivolol, at any dose) for at least 12 months
• People who have been on the full recommended heart failure medication plan for at least 12 months, including the highest tolerated doses of an SGLT2 inhibitor and a blood pressure/heart medication from a specific group (such as an ACE inhibitor, ARB, or ARNI), and a mineralocorticoid receptor antagonist if tolerated — with no major changes to these medications in the 3 months before joining
• People with or without an implanted heart device (ICD)
• People able to give written consent to participate
• People registered with French Social Security (confirm with trial site if this applies outside France)

Who may not be able to join:

• People who have had irregular heart rhythms (such as atrial or ventricular arrhythmias) in the past 12 months, or whose irregular heart rhythm requires treatment with a beta-blocker
• People with high blood pressure that is not well controlled, as assessed by the treating doctor
• People with chest pain (angina) or signs of reduced blood flow to the heart that require beta-blocker treatment
• People who have a cardiac resynchronisation therapy (CRT) device implanted
• People who need beta-blockers for a condition unrelated to heart failure, such as migraines, tremors, complications of liver cirrhosis, or an overactive thyroid
• People who have previously had a serious relapse of heart failure or dangerous heart rhythm problems when beta-blockers were stopped
• People with severe heart valve disease, certain specific types of heart muscle disease, a stiff or inflamed lining around the heart, or recent heart inflammation within the past 3 months
• People who have a planned procedure to clear blocked arteries in the heart, neck, or legs at the time of joining
• People with severe kidney disease (kidney function below a certain threshold, as measured by a blood test) (confirm specific value with trial site)
• People with significant liver failure (classified as Child-Pugh B or C) (confirm with trial site)
• People who have had an organ transplant in the past, or who are expected to need one within the next 12 months
• People with another serious condition besides heart failure that may limit life expectancy to less than one year
• People who are pregnant, breastfeeding, or of childbearing potential without a reliable method of contraception
• People currently taking part in another clinical intervention trial
• People who are under a legal protection order or guardianship
• People whose safety or ability to follow the study plan may be at risk, as assessed by the treating doctor

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