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

Trial ID or NCT#

NCT04164732

Status

not recruiting iconNOT RECRUITING

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:
  2. * 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
    1. Other protocol-defined inclusion/exclusion criteria may apply
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Investigator(s)

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

View on ClinicalTrials.gov