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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00001960
Eligibility Criteria:
INCLUSION CRITERIA:
Children of either gender, aged 4 to 18 years.
Obstructive HCM defined as LV hypertrophy, and an LV intra-cavitary pressure gradient measured at cardiac catheterization of greater than or equal to 30 mm Hg at rest or greater than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than or equal to 100 beats per minute.
Cardiac symptoms (chest discomfort, dyspnea, lightheadedness or presyncope, syncope, cardio-respiratory arrest, palpitations, excessive fatigue); and/or exercise duration which is less than 10th percentile predicted for age/gender despite a trial of a beta-blocker therapy and a trial of verapamil therapy.
EXCLUSION CRITERIA:
Other systemic diseases that prevent assessment by exercise tests and cardiac catheterization.
Chronic atrial fibrillation.
Positive pregnancy test: A negative urine pregnancy test will be required before each cardiac catheterization, electrophysiologic study and thallium study. Pregnant or lactating subjects may not participate in the study due to potential teratogenic effects of radiation.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001960
Study Brief:
Protocol Section:
NCT00001960