Phase 3 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 whose heart condition is significantly affecting their quality of life, based on a specific symptom score (called the KCCQ CSS) of less than 85
• People whose heart condition limits their physical activity to a moderate or slight degree (known as NYHA Class II or III)
• People who have been diagnosed with hypertrophic cardiomyopathy (HCM) — a condition where the heart muscle is abnormally thick without another obvious cause — with a wall thickness of 15mm or more, or 13mm or more if a close family member also has HCM
• People with the obstructive form of HCM (oHCM), where a specific measurement of blood flow restriction in the heart (LVOT peak gradient) is 30 mmHg or above, measured by ultrasound at rest or during a specific breathing test
• People with the non-obstructive form of HCM (nHCM), where that same blood flow measurement stays below 30 mmHg both at rest and during the breathing test
• People whose heart pumping function (called ejection fraction) is at least 50%, or at least 55% for those already taking a cardiac myosin inhibitor medication
• People already taking a cardiac myosin inhibitor, provided the dose has been stable for at least 3 months before screening and no dose increase is planned during the trial
• People whose other heart-related medications (such as beta-blockers, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, or water tablets) have been at a stable dose for at least 1 month before screening

Who may not be able to join:

• People who have taken an SGLT2 inhibitor medication (a type of drug often used for diabetes or heart failure) within the past 8 weeks before screening
• People who have previously had a bad reaction or intolerance to an SGLT2 inhibitor
• People who have ever been treated with sotagliflozin (a specific type of SGLT2 inhibitor)
• People currently taking thiazolidinediones (a type of diabetes medication) or digoxin (a heart medication)
• People currently taking part in, or who have recently taken part in, another clinical trial involving an experimental treatment within 45 days of screening
• People whose thickened heart muscle is caused by a known storage or infiltrative disease such as Fabry disease, amyloidosis, or Noonan syndrome, rather than true HCM
• People who have had an unexplained blackout or fainting episode within the 6 months before screening
• People who have had a serious fast heart rhythm episode lasting more than 30 seconds, or whose implanted defibrillator device has delivered a shock, within the 6 months before screening
• People who have an irregular heart rhythm called atrial fibrillation and are not on blood-thinning medication, or whose heart rate from the atrial fibrillation has not been adequately controlled within 3 months of screening
• People who are planning to have a procedure to reduce the thickness of the heart wall (septal reduction therapy) during the trial, or who had such a procedure less than 3 months before screening
• People who have had heart surgery, a heart artery procedure, or a heart device implanted (such as a pacemaker or defibrillator) within 3 months before screening, or who have any of these planned during the trial
• People who have a cardiac resynchronisation therapy (CRT) device
• People who have had an acute coronary syndrome (a sudden, serious heart event) within 2 months before screening
• People who have had a stroke or heart attack within 6 months before screening
• People who were hospitalised for heart failure or a heart rhythm problem within 4 weeks before screening
• People who have moderate or severe narrowing of the aortic valve (aortic stenosis)
• People who have chest pain or significant reduced blood flow to the heart due to unstable coronary artery disease

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