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Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
Recruiting
Trial ID: NCT04164732
Purpose
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
Associate Professor of Medicine (Cardiovascular Medicine)
Eligibility
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
Intervention(s):
drug: LCZ696
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305