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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01721967
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Left Ventricle wall thickness \>/= 15mm in the absence of other condition causing hypertrophy
* Baseline Angina/Shortness of Breath Frequency of \> 2 episodes per week
* Willing to provide informed consent
Exclusion Criteria:
* Severe stenotic valvular disease
* Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion
* Significant (\>60% stenosis) coronary artery disease
* Acute coronary syndrome within 30 days
* Severe heart failure defined as LV systolic dysfunction with Ejection Fraction \<40% or NYHA class 4 symptoms
* Severe renal impairment (glomerular filtration rate, \<30 mL/min/1.73 m2)
* Moderate-severe hepatic impairment (Child-Pugh classes B and C)
* Hospitalization for cardiac reason within 3 months of enrollment
* Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies
* Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors
* Active myocarditis, pericarditis, or restrictive cardiomyopathy
* Non-cardiac terminal illness with expected survival less than 6 months
* Women who are of childbearing potential
* Inability to perform or adhere to study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01721967
Study Brief:
Protocol Section:
NCT01721967