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)

  • End date
    Nov 22, 2023
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 October 2022
exercise test
cardiopulmonary exercise testing
hypertrophic obstructive 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.

Condition Cardiomyopathy, Hypertrophic
Treatment Placebo, LCZ696
Clinical Study IdentifierNCT04164732
SponsorNovartis Pharmaceuticals
Last Modified on21 October 2022


Yes No Not Sure

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
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