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

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)

ClinicalTrials.gov Identifier: NCT04164732

Novartis Reference Number: CLCZ696I12201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Cardiomyopathy, Hypertrophic
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
44 participants
Start date 
Jan 08, 2020
Completion date 
May 23, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

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

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 Locations

United States
Novartis Investigative Site
Recruiting
Stanford, 94305-5826
California
United States
Novartis Investigative Site
Recruiting
Boston, 02111
Massachusetts
United States
Novartis Investigative Site
Recruiting
Boston, 02114
Massachusetts
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Ann Arbor, 48109 5271
Michigan
United States
Novartis Investigative Site
Recruiting
Morristown, 07960
New Jersey
United States
Finland
Novartis Investigative Site
Recruiting
Tampere, 33520
-
Finland
Germany
Novartis Investigative Site
Recruiting
Berlin, 10789
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Kiel, 24105
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 151 23
GR
Greece
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Spain
Novartis Investigative Site
Recruiting
El Palmar, 30120
Murcia
Spain
Novartis Investigative Site
Recruiting
Madrid, 28222
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]