Hypertrophic Cardiomyopathy Clinical Trial

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT04164732

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 17 Locations for this study

See Locations Near You

Novartis Investigative Site
Stanford California, 94305, United States
Novartis Investigative Site
Boston Massachusetts, 02114, United States
Novartis Investigative Site
Ann Arbor Michigan, 48109, United States
Novartis Investigative Site
Portland Oregon, 97239, United States
Novartis Investigative Site
Berlin , 10789, Germany
Novartis Investigative Site
Hamburg , 20246, Germany
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Kiel , 24105, Germany
Novartis Investigative Site
Athens GR, 151 2, Greece
Novartis Investigative Site
Heraklion Crete , 711 1, Greece
Novartis Investigative Site
Seoul , 03722, Korea, Republic of
Novartis Investigative Site
Seoul , 05505, Korea, Republic of
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
El Palmar Murcia, 30120, Spain
Novartis Investigative Site
Madrid , 28079, Spain
Novartis Investigative Site
Madrid , 28222, Spain
Novartis Investigative Site
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT04164732

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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