Phase 3 Heart Disease 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 who are at least 18 years old (or the legal age of consent in their country, if older than 18)
• People who are willing and able to sign a formal consent form before the trial begins
• Men or women — though women who could become pregnant must be willing and able to use a highly effective form of birth control (one with a failure rate below 1% per year when used correctly and consistently)
• People who have been diagnosed with chronic heart failure for at least 3 months before the first visit, are in a moderate-to-severe stage of heart failure (NYHA Class II to IV), and whose heart pumps less than 40% of the blood it should with each beat, as confirmed by a heart scan
• People who have elevated levels of a specific heart stress marker in their blood (called NT-proBNP), measured at a central laboratory at the first visit
• People who are already receiving the best available standard treatment for heart failure, not including two specific types of medication (SGLT2 inhibitors and MRAs)

(Note: Additional inclusion criteria apply — confirm with the trial site)

Who may not be able to join:

• People who have taken certain water-retaining/potassium-sparing medications (such as spironolactone, eplerenone, finerenone, or amiloride) in the 14 days before the first visit, or who the treating doctor expects will need these medications before or during the trial — importantly, these medications must not be stopped specifically in order to try to join the trial
• People who are taking certain specific heart or blood pressure medications at the time of a key trial visit, including a direct renin inhibitor (e.g. aliskiren), more than one type of ACE inhibitor/ARB/ARNi at the same time, other aldosterone synthase inhibitors (e.g. baxdrostat), or systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)
• People whose heart failure has recently become severely unstable and who have needed certain emergency treatments — such as intravenous heart-stimulating drugs, blood vessel-widening drugs, mechanical heart support, or increased doses of intravenous fluid-removal drugs — very recently before the trial's randomisation point
• People who have had a heart attack, mini-stroke, stroke, major heart surgery, or other major surgery within the 90 days before a key trial visit, or who have a major surgery planned
• People who have had a heart procedure involving a small tube inserted into a blood vessel (PCI), or a scan using iodinated contrast dye, within 7 days before a key trial visit
• People who have had a heart transplant, are waiting for one, or who have a mechanical heart pump (LVAD) already implanted
• People whose heart failure is caused by certain specific underlying diseases (such as amyloidosis, haemochromatosis, Fabry disease, muscular dystrophy, hypertrophic obstructive cardiomyopathy, or pericardial constriction), or whose heart condition may be reversible (such as stress-related, pregnancy-related, or chemotherapy-related cardiomyopathy occurring within 12 months before the first visit)
• People who have had acute inflammatory heart disease (such as acute myocarditis) within 90 days before the first visit

(Note: Additional exclusion criteria apply — confirm with the trial site)

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