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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT04580693
Eligibility Criteria:
Inclusion Criteria for Endurance Athletes:
* Age ≥ 18-60
* Official participation in a collegiate varsity rowing team OR participation in competitive endurance athletics (defined as \>= 10 hours of exercise training per week with the majority dedicated to endurance activities (i.e. cycling, rowing, running).
Inclusion Criteria for Healthy Volunteers:
* Age ≥ 18-60
* 0-5 hours of exercise per week without anticipated changes in exercise habits over study period
* Able to exercise on an upright bicycle ergometer
Exclusion Criteria for Endurance Athletes and Healthy Volunteers:
* Known medical disease (including but not limited to known cardiac or pulmonary disease, diabetes or contraindications to exercise testing such as uncontrolled cardiac arrhythmia, excessive blood pressure of more than 200/100 mmHg at rest, active exacerbation of congestive heart failure or reactive airways disease).
* Pregnancy
Inclusion Criteria for HCM Patients:
* Established HCM diagnosis as per above (20 subjects)
* Age ≥ 18-50
* No anticipated changes to baseline exercise program (if any) over the study period
* Able to exercise on an upright bicycle ergometer
Exclusion Criteria for HCM Patients:
* Obstructive LVOT gradient \> 30 mmHg, at rest or with provocation.
* Reduced LVEF \< 53%.
* NYHA class III or IV heart failure symptoms.
* History of sudden cardiac death or hemodynamically significant ventricular tachycardia.
* History of unexplained syncope.
* Having a Class I or IIa AHA/ACC indication for ICD placement without an ICD
* Known medical disease (including but not limited to known cardiac or pulmonary disease other than HCM, diabetes, or contraindications to exercise testing such as uncontrolled cardiac arrhythmia, excessive blood pressure of more than 200/100 mmHg at rest, active exacerbation of congestive heart failure or reactive airways disease).
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04580693
Study Brief:
Protocol Section:
NCT04580693