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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT04164732
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Hypertrophic Cardiomyopathy with a left ventricular wall thickness greater than or equal to 13mm as determined by the echocardiogram obtained during the screening/baseline period
* Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiogram obtained during the screening/baseline period
* Symptoms consistent with New York Heart Association (NYHA) Class II-III heart failure by physician assessment, or asymptomatic/NYHA Class I patients with:
* NT-proBNP blood sample levels above 250 pg/ml and
* peak VO2 of less than or equal to 80% of predicted based on age and gender as determined by cardiopulmonary exercise testing
Exclusion Criteria:
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for ≥7 days after stopping study drug
* Patients with a resting or provokable left ventricular outflow tract gradient of greater than or equal to 30mm Hg
* Septal reduction procedure within 3 months of the screening/baseline visit
* History of atrial fibrillation within 6 months of the screening/baseline visit or placement of ICD for secondary prevention
* Patients with a peak VO2 on the screening/baseline cardiopulmonary exercise test of \> 80% of predicted based on age and gender
* Patients who require treatment with ACE inhibitors, angiotensin receptor blockers (ARBs), or renin inhibitors
* Known infiltrative or storage disorder such as Fabry disease, or amyloidosis
* Known or suspected symptomatic coronary artery diseases or evidence of prior myocardial infarction
* Systolic blood pressure of \<100 mmHg or symptomatic hypotension during the screening/baseline period or treatment run-in period
* Contraindication to ARB administration or prior history of angioedema
* Persistent uncontrolled hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04164732
Study Brief:
Protocol Section:
NCT04164732