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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• 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: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/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 Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

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: Placebo

Drug: LCZ696

Primary Outcome(s)

Change from baseline in peak VO2 as measured by cardiopulmonary exercise test (CPET) [Time Frame: Baseline to 50 weeks]

Secondary ID(s)

2019-003098-24

CLCZ696I12201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors