Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy


Trial ID: NCT04164732


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.

Official Title

A Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)

Stanford Investigator(s)

Matthew Wheeler
Matthew Wheeler

Associate Professor of Medicine (Cardiovascular Medicine)


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


drug: LCZ696

drug: Placebo


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305