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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT01127061
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years and ≤ 80.
* Diagnosis of HCM, defined by the presence of unexplained left-ventricular hypertrophy \> 13 mm in any wall segment.
* Agreement to be a participant in the study protocol and willing/able to return for follow-up.
Exclusion Criteria:
* History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
* Medically refractory left ventricular outflow tract obstruction being evaluated for septal reduction therapy.
* Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
* Hypotensive response to exercise (\> 20 mm Hg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
* Pregnancy.
* Implantable Cardioverter-Defibrillator (ICD) placement in last 3 months or scheduled.
* Left ventricular systolic dysfunction (left ventricular ejection fraction \< 55% by echocardiography).
* Worsening clinical status in the last 3 months, advanced heart failure (New York Heart Association class IV symptoms) or angina (Canadian Cardiovascular Society class IV symptoms).
* Life expectancy less than 12 months.
* Inability to exercise due to orthopedic or other non-cardiovascular limitations.
* Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01127061
Study Brief:
Protocol Section:
NCT01127061