Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to determine if LCZ696 is safe, tolerable and can improve
 exercise capacity (via improved peak VO2) in non-obstructive HCM patient population over the
 course of 50 weeks of treatment.
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

 Other protocol-defined inclusion/exclusion criteria may apply