Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03335332
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 18 - 80 years old
* Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between 13 and 15 mm along with at least one other piece of evidence of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
Exclusion Criteria:
* A history of exercise-induced syncope or arrhythmias (ventricular tachycardia; sustained or non-sustained)
* Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
* Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
* Pregnancy
* Worsening clinical status or advanced heart failure (New York Heart Association class IV symptoms)
* A hypotensive responsive to exercise (an increase in exercise systolic BP throughout the exercise test of \< 20mmHg compared with resting values, or an initial increase in systolic BP \> 20mmHg with a subsequent fall by peak exercise of \> 20mmHg, or a continuous decrease in systolic BP throughout the test of \> 20mmHg, compared with baseline BP)
* Left ventricular systolic dysfunction (left ventricular ejection fraction \< 55 % by echocardiography)
* Coronary artery disease as evidenced by prior myocardial infarction or angina
* Cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
* A chronic orthopaedic injury which limits the ability to exercise
* Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03335332
Study Brief:
Protocol Section:
NCT03335332