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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 22, 2023

Interventions

  • Drug: LCZ696
    • LCZ696 at doses of 50mg, 100mg and 200mg b.i.d oral
  • Drug: Placebo
    • placebo

Arms, Groups and Cohorts

  • Experimental: LCZ696 at doses of 50mg, 100mg and 200mg b.i.d
    • randomized in a 1:1 ratio: LCZ696 to placebo
  • Placebo Comparator: Placebo to LCZ696
    • randomized in a 1:1 ratio: LCZ696 to placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in peak VO2 as measured by cardiopulmonary exercise test (CPET)
    • Time Frame: Baseline to 50 weeks
    • The primary analysis will assess the effect of LCZ696 on the change from baseline in peak VO2 (ml/kg/min) at week 50 compared to placebo, where baseline peak VO2 will come from the screening/baseline CPET.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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