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)

STATUS

Recruiting
End date

Nov 22, 2023
participants needed

44
sponsor

Novartis Pharmaceuticals

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Updated on 21 October 2022

See if I qualify

nt-probnp

cpet

hypertrophy

exercise test

cardiopulmonary exercise testing

hypertrophic obstructive cardiomyopathy

Summary

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.

Details

Condition	Cardiomyopathy, Hypertrophic
Treatment	Placebo, LCZ696
Clinical Study Identifier	NCT04164732
Sponsor	Novartis Pharmaceuticals
Last Modified on	21 October 2022

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Eligibility		Yes	No	Not Sure
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

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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)