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NCT04164732

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

Completed Phase 2 Results posted Last updated 16 May 2025
What this trial tests

Phase 2 trial testing LCZ696 in Cardiomyopathy, Hypertrophic in 46 participants. Completed in 22 August 2023.

Timeline
8 January 2020
Primary endpoint
22 August 2023
22 August 2023

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment46
Start date8 January 2020
Primary completion22 August 2023
Estimated completion22 August 2023
Sites18 locations across Greece, United Kingdom, Germany, South Korea, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Cardiomyopathy, Hypertrophic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET) Primary · Baseline to 50 weeks

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.

GroupValue95% CI
LCZ696 BID1.00-0.22 – 2.23
Placebo BID0.39-0.80 – 1.58

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.. Reporting threshold: 4.99%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Run-In Period Placebo
Serious: 0/46 (0%)
Deaths: 0/46
Run-In LCZ696 50 mg
Serious: 0/43 (0%)
Deaths: 0/43
Double-blind Period Placebo
Serious: 0/20 (0%)
Deaths: 0/20
Double-blind Period LCZ696 50 mg
Serious: 0/1 (0%)
Deaths: 0/1
Double-blind Period LCZ696 100 mg
Serious: 1/20 (5%)
Deaths: 0/20
Double-blind Period LCZ696 200 mg
Serious: 2/17 (12%)
Deaths: 0/17
Double-blind Period LCZ696
Serious: 3/20 (15%)
Deaths: 0/20
Total
Serious: 3/46 (7%)
Deaths: 0/46

Serious adverse events (7 terms)

ReactionSystemRun-In Period PlaceboRun-In LCZ696 50 mgDouble-blind Period PlaceboDouble-blind Period LCZ696…Double-blind Period LCZ696…Double-blind Period LCZ696…Double-blind Period LCZ696Total
Atrioventricular block second degreeCardiac disorders
BradycardiaCardiac disorders
Bundle branch block leftCardiac disorders
Bundle branch block rightCardiac disorders
Cardiac failureCardiac disorders
Coronary artery diseaseCardiac disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
Other adverse events (32 terms — click to expand)

ReactionSystemRun-In Period PlaceboRun-In LCZ696 50 mgDouble-blind Period PlaceboDouble-blind Period LCZ696…Double-blind Period LCZ696…Double-blind Period LCZ696…Double-blind Period LCZ696Total
COVID-19Infections and infestations
DizzinessNervous system disorders
HypotensionVascular disorders
DiarrhoeaGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
VomitingGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
Sleep apnoea syndromeRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
PalpitationsCardiac disorders
VertigoEar and labyrinth disorders
Gastric disorderGastrointestinal disorders
Gastrointestinal sounds abnormalGastrointestinal disorders
AstheniaGeneral disorders
Chest painGeneral disorders
OedemaGeneral disorders
CystitisInfections and infestations
Diarrhoea infectiousInfections and infestations
DiverticulitisInfections and infestations
Respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Foreign body in eyeInjury, poisoning and procedural complications
SARS-CoV-2 test positiveInvestigations
Abnormal loss of weightMetabolism and nutrition disorders
GoutMetabolism and nutrition disorders
SyncopeNervous system disorders
Tension headacheNervous system disorders
NocturiaRenal and urinary disorders
Renal impairmentRenal and urinary disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
AngioedemaSkin and subcutaneous tissue disorders

Most-reported serious reactions: Atrioventricular block second degree, Bradycardia, Bundle branch block left, Bundle branch block right, Cardiac failure, Coronary artery disease, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT04164732 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting ferroptosis as a promising therapeutic strategy to treat cardiomyopathy.
    Sun H, Chen D, Xin W, Ren L, et al · · 2023 · cited 16× · PMID 37138856 · DOI 10.3389/fphar.2023.1146651
  2. Pushing the Limits of Medical Management in HCM: A Review of Current Pharmacological Therapy Options.
    Stătescu C, Enachi Ș, Ureche C, Țăpoi L, et al · · 2021 · cited 8× · PMID 34281272 · DOI 10.3390/ijms22137218
  3. Clinical Trials in Hypertrophic Cardiomyopathy Therapy: A Comprehensive Analysis of Trials Registered in Global Clinical Databases.
    Zhang H, Yu C, Cheng Y, Chen Z, et al · · 2023 · cited 4× · PMID 37377648 · DOI 10.2147/dddt.s413136
  4. Circulating Cardiovascular Proteomic Associations With Genetics and Disease.
    McGurk KA, Curran L, Sau A, Ng FS, et al · · 2025 · cited 1× · PMID 41054850 · DOI 10.1161/circgen.124.005005

Verify or expand the search:

Other trials of LCZ696

Trials testing the same drug.

Other recruiting trials for Cardiomyopathy, Hypertrophic

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04164732.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing