. Author manuscript; available in PMC: 2017 Sep 6.

Published in final edited form as: Am Heart J. 2017 Feb 16;187:145–155. doi: 10.1016/j.ahj.2017.02.008

Table II.

Eligibility criteria for the VANISH trial

Inclusion Criteria	Exclusion Criteria
Primary analysis cohort Age 8 to 45 years LV wall thickness ≥ 12 mm and ≤25 mm or z-score ≥ 3 and ≤18 as determined by rapid assessment by the echocardiographic core laboratory NYHA functional class I or II No resting or provoked LV obstruction (peak gradient ≤30 mm Hg) Exploratory analysis cohort Age 10 to 25 years LV wall thickness< 12 mm and z score< 3 as determined by rapid assessment by the echocardiographic core laboratory Evidence of phenotypic expression: early diastolic relaxation velocity (E′) z-score ≤ −1.5 or electrocardiographic abnormalities other than non-specific ST-T wave changes (e.g., Q waves, T wave inversion, repolarization changes) or LV wall thickness z-score 1.5 to 2.9 combined with LV thickness to dimension ratio ≥ 0.19 as determined by rapid assessment by the echocardiographic core laboratory	Contraindication to angiotensin receptor blocker (ARB) administration Medical conditions that may confound interpretation of biomarkers of collagen synthesis (fibrosis, inflammatory states, cancer, trauma or surgery within 6 months of enrollment) Concomitant use of spironolactone, lithium, aliskiren, ARB, or angiotensin converting enzyme (ACE)-inhibitors. Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method Uncontrolled systemic arterial hypertension (persistent systolic blood pressure> 160 mmHg and/or diastolic blood pressure> 90 mmHg in adults or equivalent in children [e.g., systolic blood pressure > 99th or diastolic blood pressure> 95th percentile for sex, age, and height centile based on the American Academy of Pediatrics normal values]) Prior septal myectomy, alcohol septal ablation, or treatment for symptomatic heart failure Known or suspected coronary artery disease or evidence of prior myocardial infarction based on symptoms or cardiac imaging More than mild valvular heart disease, clinically relevant congenital heart disease, or left ventricular ejection fraction (LVEF) <55% Secondary prevention implantable cardioverter-defibrillator (ICD) or history of appropriate ICD therapy

Inclusion Criteria

Exclusion Criteria

Primary analysis cohort

Age 8 to 45 years
LV wall thickness ≥ 12 mm and ≤25 mm or z-score ≥ 3 and ≤18 as determined by rapid assessment by the echocardiographic core laboratory
NYHA functional class I or II
No resting or provoked LV obstruction (peak gradient ≤30 mm Hg)

Exploratory analysis cohort

Age 10 to 25 years
LV wall thickness< 12 mm and z score< 3 as determined by rapid assessment by the echocardiographic core laboratory
Evidence of phenotypic expression: early diastolic relaxation velocity (E′) z-score ≤ −1.5 or electrocardiographic abnormalities other than non-specific ST-T wave changes (e.g., Q waves, T wave inversion, repolarization changes) or LV wall thickness z-score 1.5 to 2.9 combined with LV thickness to dimension ratio ≥ 0.19 as determined by rapid assessment by the echocardiographic core laboratory

Contraindication to angiotensin receptor blocker (ARB) administration
Medical conditions that may confound interpretation of biomarkers of collagen synthesis (fibrosis, inflammatory states, cancer, trauma or surgery within 6 months of enrollment)
Concomitant use of spironolactone, lithium, aliskiren, ARB, or angiotensin converting enzyme (ACE)-inhibitors.
Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
Uncontrolled systemic arterial hypertension (persistent systolic blood pressure> 160 mmHg and/or diastolic blood pressure> 90 mmHg in adults or equivalent in children [e.g., systolic blood pressure > 99th or diastolic blood pressure> 95th percentile for sex, age, and height centile based on the American Academy of Pediatrics normal values])
Prior septal myectomy, alcohol septal ablation, or treatment for symptomatic heart failure
Known or suspected coronary artery disease or evidence of prior myocardial infarction based on symptoms or cardiac imaging
More than mild valvular heart disease, clinically relevant congenital heart disease, or left ventricular ejection fraction (LVEF) <55%
Secondary prevention implantable cardioverter-defibrillator (ICD) or history of appropriate ICD therapy