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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04164732
Date of registration: 13/11/2019
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
Scientific title: 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)
Date of first enrolment: January 8, 2020
Target sample size: 44
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04164732
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Finland Germany Greece Korea, Republic of Spain United States
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone: 1-888-669-6682
Email: novartis.email@novartis.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cardiomyopathy, Hypertrophic
Intervention(s)
Drug: LCZ696
Drug: Placebo
Primary Outcome(s)
Change from baseline in peak VO2 as measured by cardiopulmonary exercise test (CPET) [Time Frame: Baseline to 50 weeks]
Secondary Outcome(s)
Secondary ID(s)
2019-003098-24
CLCZ696I12201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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