Early Phase 1 Cardiomyopathy 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:

• Adults aged 18 or older, of any sex
• People who are willing and able to sign a consent form agreeing to take part in the study
• People who are available for the full length of the study and willing to follow all study procedures
• People who are able to swallow tablets and are willing to take the study medication as directed
• Women who could become pregnant must have been using a highly effective form of contraception for at least 1 month before screening, and must agree to continue using it throughout the study and for 2 weeks after the last dose of study medication
• People who have been diagnosed with a heart condition called hypertrophic cardiomyopathy (HCM) with a specific level of symptoms — either moderate to significant limitation of physical activity, or minimal symptoms combined with a lower-than-expected exercise capacity on a breathing and exercise test
• People whose heart has a specific type of blockage measurement (left ventricular outflow tract gradient) below 50 mmHg at rest, during a breathing manoeuvre, and during exercise
• People whose heart pumping function (ejection fraction) is above 50%, confirmed by a heart scan (echocardiogram or MRI) done within the past year and again at the first study visit
• People whose heart medications have been stable and unchanged for at least 1 month before joining the study

Who may not be able to join:

• People who have taken a type of diabetes medication called an SGLT2 inhibitor within the past 8 weeks, or who have had a bad reaction to one in the past
• People with Type 1 diabetes
• People under 18 years of age
• Women who are pregnant or breastfeeding (a urine pregnancy test will be done at the screening visit for women who could become pregnant)
• People with uncontrolled atrial fibrillation (an irregular heart rhythm) where the resting heart rate is above 100 beats per minute at the baseline assessment
• People with a type of irregular heart rhythm (paroxysmal atrial fibrillation or flutter) where there are plans during the study period to restore normal rhythm using medication, a procedure called ablation, or an electrical shock treatment
• People who were not able to reach a sufficient level of effort on a breathing and exercise test (cardiopulmonary exercise test) on the screening day (confirm with trial site)
• People who have had a heart procedure to reduce the thickness of the heart wall (septal reduction therapy) within the past 3 months
• People who are scheduled to have a type of heart device implanted (implantable cardioverter-defibrillator, or ICD) during the study period
• People who have had a cardiac resynchronisation therapy (CRT) device implanted within the past 12 weeks, or who plan to have one implanted during the study
• People with a low red blood cell level (haemoglobin below 10 g/dL)
• People with significantly reduced kidney function or rapidly worsening kidney disease at the time of joining the study
• People who are unwilling or unable to exercise
• People with more than moderate disease affecting the valves on the left side of the heart, moderate or greater narrowing of the mitral valve, or severe disease of the valves on the right side of the heart, based on a heart scan at enrolment
• People currently experiencing chest pain caused by significant blockages in the heart's own arteries, as assessed by the study doctor
• People who have had a heart attack or a heart artery procedure within the past 2 months
• People with a specific type of high blood pressure in the lungs (WHO Group 1 Pulmonary Arterial Hypertension)
• People with significant lung disease, including advanced chronic obstructive pulmonary disease (Stage III or higher), oral steroid treatment for a lung flare-up in the past 6 months, or current use of supplemental oxygen (other than overnight oxygen for sleep apnoea)
• People with significant reduced blood flow to the heart found on a stress test, unless they have since had a procedure to address it, a scan confirming no significant blockages, or a follow-up stress test with a normal result
• People with a very slow heart rate causing symptoms, or a significant heart rhythm conduction problem (second- or third-degree heart block), and who do not have a pacemaker
• People with significant liver disease affecting liver function, based on specific blood test results (confirm with trial site)
• People with severe dysfunction of the right side of the heart, seen on a baseline heart scan
• People who experience a significant drop in blood pressure (more than 20 mmHg) when standing up from lying down
• People currently taking part in another clinical trial involving an experimental treatment (observational studies and registries are permitted)
• People with any other condition that, in the study doctor's opinion, would prevent them from completing the study, including certain health conditions, mental health conditions, or practical barriers such as difficulty travelling to the exercise facility

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