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)
2 other identifiers
interventional
46
6 countries
18
Brief Summary
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2020
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
January 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2023
CompletedResults Posted
Study results publicly available
August 29, 2024
CompletedMay 16, 2025
May 1, 2025
3.6 years
November 13, 2019
August 5, 2024
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET)
The primary analysis assessed the effect of LCZ696 on the change from baseline in peak Volume of Oxygen (VO2) (ml/kg/min) at week 50 compared to placebo, where baseline peak VO2 came from the screening/baseline CPET. An increase in peak VO2 (mL/kg/min)/positive change is considered beneficial for the patient.
Baseline to 50 weeks
Study Arms (2)
LCZ696 BID
EXPERIMENTALPatients were treated with LCZ696. The target dose level was 200 mg p.o. b.i.d.
Placebo BID
PLACEBO COMPARATORPlacebo to LCZ696
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Novartis Investigative Site
Stanford, California, 94305-5826, United States
Novartis Investigative Site
Boston, Massachusetts, 02114, United States
Novartis Investigative Site
Ann Arbor, Michigan, 48109 5271, United States
Novartis Investigative Site
Morristown, New Jersey, 07960, 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 23, Greece
Novartis Investigative Site
Heraklion Crete, 711 10, Greece
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
El Palmar, Murcia, 30120, Spain
Novartis Investigative Site
Valencia, Valencia, 46010, Spain
Novartis Investigative Site
Madrid, 280796, Spain
Novartis Investigative Site
Madrid, 28222, Spain
Novartis Investigative Site
London, EC1A 7BE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Investigator and subject will be blinded to treatment allocation during the treatment period
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2019
First Posted
November 15, 2019
Study Start
January 8, 2020
Primary Completion
August 22, 2023
Study Completion
August 22, 2023
Last Updated
May 16, 2025
Results First Posted
August 29, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.