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

Trial ID or NCT#

NCT04164732

Status

recruiting iconRECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Investigator(s)

Matthew Wheeler
Matthew Wheeler
Cardiologist, Heart failure cardiologist
Associate Professor of Medicine (Cardiovascular Medicine)

View on ClinicalTrials.gov