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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cardiomyopathy, Hypertrophic

In brief

The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.

Key facts

Study ID

NCT04164732

Run by

Novartis Pharmaceuticals

People needed

46

Starts

2020-01-08

Expected to finish

2023-08-22

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Stanford, California, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Morristown, New Jersey, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — Athens, GR, Greece
• Novartis Investigative Site — Heraklion Crete, Greece
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — El Palmar, Murcia, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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