Clinical Trials

Numerous clinical trials evaluate sacubitril/valsartan (LCZ696) from Phase 1 through Phase 4 across cardiovascular conditions, including heart failure with reduced ejection fraction, hypertension, left ventricular hypertrophy, and post-myocardial infarction. Supported by diverse sponsors ranging from Novartis to academic medical centers like Brigham and Women's Hospital and The Cleveland Clinic, these studies include completed, actively recruiting, and suspended protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06704633 RECRUITING
Heart Failure
Martin Rohacek
 2026-06-30 PHASE4
NCT05194111 RECRUITING
Heart Failure; Heart Dysfunction
Virginia Commonwealth University
 2022-08-11 PHASE1; PHASE2
NCT07491718 RECRUITING
Takotsubo Cardiomyopathy
University of Edinburgh
 2025-08-08
NCT05508035 RECRUITING
Heart Failure With Moderately Reduced Ejection Fraction
John Paul II Hospital, Krakow
 2023-07-13 PHASE3
NCT07572032 RECRUITING
Heart Failure Due to Coronary Artery Disease; Valvular Cardiomyopathy; Heart Failure
Kyungsub Song
 2026-05-20 PHASE4
NCT05465031 RECRUITING
Breast Cancer; Neoplasm, Breast; Breast Diseases; Antihypertensive Agents; Sacubitril/Valsartan; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Heart Failure; Cardiac Toxicity; Cancer, Therapy-Related; Cancer Therapy-Related Cardiac Dysfunction; Cardiotoxicity
Silesian Centre for Heart Diseases
 2024-04-17 PHASE4
NCT05279742 ENROLLING_BY_INVITATION
Heart Failure With Preserved Ejection Fraction; Chronic Kidney Diseases
Horng Chen
 2022-11-04 PHASE1; PHASE2
NCT06712030 NOT_YET_RECRUITING
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Puerta de Hierro University Hospital
 2025-01 PHASE3
NCT04971720 RECRUITING
Obesity; Cardiovascular Diseases; Hypertension; Nocturnal Blood Pressure; Natriuretic Peptides; Renin-Angiotensin-Aldosterone System
University of Alabama at Birmingham
 2022-02-18 PHASE2; PHASE3
NCT04055428 RECRUITING
Diabetes Mellitus; Cardiovascular Diseases; Insulin Sensitivity/Resistance; Metabolic Disease; Natriuretic Peptides; Metabolism; Energy Expenditure
University of Alabama at Birmingham
 2020-08-15 PHASE2
NCT06693674 RECRUITING
Congenital Heart Disease
Mayo Clinic
 2025-02-03 PHASE3
NCT06917664 RECRUITING
Coronary Artery Disease; Ischemic Mitral Regurgitation; Angiotensin Receptor/Neprilysin Inhibitor
China National Center for Cardiovascular Diseases
 2025-06-05 PHASE4
NCT06900803 NOT_YET_RECRUITING
Heart Failure With Reduced Ejection Fraction (HFrEF); Sacubitril/Valsartan; Medication Adherence
National Taiwan University Hospital
 2025-04-07
NCT06536309 WITHDRAWN
Heart Failure With Preserved Ejection Fraction; Myocardial Fibrosis
Brigham and Women's Hospital
 2026-08-27 PHASE4
NCT03508739 SUSPENDED
Diabetes Mellitus, Type 2; Pre-diabetic; Hypertension; Elevated Blood Pressure
University of Pennsylvania
 2018-06-01 PHASE3
NCT07417215 COMPLETED
Heart Failure With Preserved Ejection Fraction (HFPEF); Hemodialysis; Sacubitril/Valsartan
University Clinical Hospital Mostar
 2026-01-30 PHASE4
NCT06716970 NOT_YET_RECRUITING
Essential Hypertension
Wuhan Createrna Science and Technology Co., Ltd
 2024-12-30 PHASE3
NCT06643819 RECRUITING
Essential Hypertension
Chong Kun Dang Pharmaceutical
 2024-10-14 PHASE3
NCT07444398 RECRUITING
Decompensated Heart Failure
Khawaja Danish Ali
 2026-01-01 PHASE1
NCT07341893 COMPLETED
Heart Failure
Damanhour University
 2025-08-01
NCT07379788 COMPLETED
Heart Failure
Rehab Werida
 2025-01-01
NCT07192341 RECRUITING
Sacubitril/Valsartan; Prosthetic Heart Valve; Heart Failure; Reduced Ejection Fraction
Kafrelsheikh University
 2025-09-27
NCT05498181 COMPLETED
Hemodialysis
Brigham and Women's Hospital
 2022-10-11 PHASE2
NCT05528419 COMPLETED
Atrial Fibrillation Recurrent; Hypertension
Shanghai Jiao Tong University School of Medicine
 2023-02-06 PHASE4
NCT06218199 RECRUITING
Heart Failure, Congestive
Heart Center Research, LLC
 2021-07-08 PHASE4
NCT05991284 COMPLETED
Heart Failure With Preserved Ejection Fraction; Functional Mitral Regurgitation
Ziekenhuis Oost-Limburg
 2024-02-29 PHASE4
NCT03744975 COMPLETED
Diabetes Mellitus, Type 2; Diastolic Dysfunction
Mayo Clinic
 2018-05-01 PHASE2
NCT05989503 COMPLETED
Heart Failure With Reduced Ejection Fraction
Universidade do Porto
 2023-08-04 PHASE4
NCT04153136 COMPLETED
HIV/AIDS; Heart Failure With Preserved Ejection Fraction
Massachusetts General Hospital
 2020-09-11 PHASE2
NCT06236061 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2024-04-08 PHASE3
NCT04649229 COMPLETED
Heart Failure
Yale University
 2021-05-27 PHASE4
NCT06501651 UNKNOWN
Essential Hypertension; Type 2 Diabetes; Nephropathy
Sichuan Academy of Medical Sciences
 2024-08-01 PHASE4
NCT04113109 COMPLETED
Heart Failure
Vanderbilt University Medical Center
 2019-11-01 PHASE4
NCT04023227 COMPLETED
Chagas Disease; Heart Failure
Novartis Pharmaceuticals
 2019-12-10 PHASE4
NCT07023016 COMPLETED
Acute Decompensated Heart Failure (ADHF); Chronic Kidney Disease (CKD)
National Heart Institute, Egypt
 2023-11-01 PHASE2; PHASE3
NCT05487261 UNKNOWN
Heart Failure
Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
 2022-12-13 PHASE4
NCT04103554 UNKNOWN
Heart Failure
University of Zagreb
 2021-02-05 PHASE4
NCT03872778 COMPLETED
Neoplasms
Advanced Accelerator Applications
 2019-07-24 PHASE1; PHASE2
NCT04853758 UNKNOWN
Chagas Cardiomyopathy
University of Sao Paulo General Hospital
 2021-05-06 PHASE3
NCT03738878 TERMINATED
Hypertension
Vanderbilt University Medical Center
 2018-11-15 PHASE4
NCT06142383 TERMINATED
Heart Failure
Novartis Pharmaceuticals
 2023-12-12 PHASE2
NCT03760588 COMPLETED
Breast Cancer Female; Heart Failure
Torbjorn Omland
 2019-01-31 PHASE2
NCT06149104 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2023-12-04 PHASE3
NCT06273254 UNKNOWN
Bioequivalence Study
Viatris Inc.
 2024-04 PHASE1
NCT06266988 UNKNOWN
Chronic Heart Failure
Viatris Inc.
 2024-03 PHASE1
NCT06357104 COMPLETED
COVID-19 Vaccine Adverse Reaction
Pachankis, Yang I., M.D.
 2024-02-26 PHASE4
NCT06090487 COMPLETED
Heart Failure
Ain Shams University
 2024-02-01
NCT06193187 UNKNOWN
Healthy Volunteers
Dr. Reddy's Laboratories (Thailand) Limited
 2024-01 PHASE1
NCT05164653 UNKNOWN
Heart Failure
Saga University
 2021-12-27 PHASE4
NCT03938389 ACTIVE_NOT_RECRUITING
PreDiabetes; Impaired Glucose Tolerance; Obesity; Blood Pressure
Ohio State University
 2020-02-25 PHASE4
NCT03785405 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2019-05-02 PHASE3
NCT05212597 UNKNOWN
Aortic Valve Insufficiency
Samsung Medical Center
 2022-01-12 PHASE2
NCT04164732 COMPLETED
Cardiomyopathy, Hypertrophic
Novartis Pharmaceuticals
 2020-01-08 PHASE2
NCT07700875 COMPLETED
Essential Hypertension
Wuhan Createrna Science and Technology Co., Ltd
 2022-12-29 PHASE2
NCT05580510 UNKNOWN
Congenital Heart Disease; Heart Failure; Heart Failure With Reduced Ejection Fraction
Instituto Nacional de Cardiologia Ignacio Chavez
 2023-02-06 PHASE2; PHASE3
NCT03928158 COMPLETED
Heart Failure; Essential Hypertension
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
 2019-05-31 PHASE2
NCT05881720 COMPLETED
Heart Failure
Damanhour University
 2022-01-01 PHASE4
NCT04883528 COMPLETED
Covid19
Duke University
 2021-08-06 PHASE1; PHASE2
NCT04637555 WITHDRAWN
Post Myocardial Infarction
Novartis Pharmaceuticals
 2021-05-26 PHASE3
NCT04929600 UNKNOWN
Hypertension; Left Ventricular Hypertrophy
Shanghai Jiao Tong University School of Medicine
 2021-11-28 PHASE4
NCT05243199 COMPLETED
CKD5 Stage Dialysis; Heart Failure
Ruijin Hospital
 2020-08-01 PHASE4
NCT05117736 TERMINATED
Systemic Right Ventricle; Heart Failure
Montreal Heart Institute
 2022-03-15
NCT03988634 COMPLETED
Heart Failure With Preserved Ejection Fraction (HFpEF)
Novartis Pharmaceuticals
 2019-06-29 PHASE3
NCT04197050 UNKNOWN
Myocardial Injury; Connective Tissue Diseases
RenJi Hospital
 2020-02-20 PHASE4
NCT04572724 UNKNOWN
Peritoneal Dialysis Complication; Hemodialysis Complication; Heart Failure
Shenzhen Second People's Hospital
 2020-07-06 PHASE4
NCT05545059 UNKNOWN
Resistant Hypertension
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2022-09-24 PHASE3
NCT05060588 UNKNOWN
Myocardial Infarction; Hypertension
Qingdao Central Hospital
 2021-10 PHASE4
NCT04637152 COMPLETED
Resistant Hypertension; Blood Pressure
Hospital Geral Roberto Santos
 2020-11-11 PHASE2
NCT03893435 COMPLETED
Acute Myocardial Infarction
The Young Investigator Group of Cardiovascular Research
 2018-12-01
NCT05053893 UNKNOWN
Cardio-Renal Syndrome
The Affiliated Hospital of Qingdao University
 2021-09-22
NCT04587947 COMPLETED
Heart Failure Patients
St. Josefs-Hospital Wiesbaden GmbH
 2020-04-01
NCT02884206 COMPLETED
Chronic Heart Failure (CHF)
Novartis Pharmaceuticals
 2016-11-23 PHASE3
NCT03832660 COMPLETED
Hypertrophic Cardiomyopathy
Newcastle University
 2019-05-03 PHASE2
NCT03553303 UNKNOWN
Heart Failure, Systolic
Oslo University Hospital
 2018-10-16 PHASE4
NCT03300427 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2018-07-05 PHASE4
NCT04191681 RECRUITING
Stage D Heart Failure
The Cleveland Clinic
 2019-11-08 PHASE4
NCT04912167 UNKNOWN
STEMI
West China Hospital
 2021-11 PHASE3
NCT05366101 COMPLETED
Hypertrophic Cardiomyopathy
Newcastle-upon-Tyne Hospitals NHS Trust
 2019-04-01 PHASE2; PHASE3
NCT02678312 COMPLETED
Pediatric Heart Failure
Novartis Pharmaceuticals
 2016-11-03 PHASE2; PHASE3
NCT04753112 COMPLETED
Pulmonary Hypertension
Germans Trias i Pujol Hospital
 2020-10-29 PHASE3
NCT05387967 COMPLETED
Heart Failure, Systolic
National Institute of Cardiovascular Diseases, Pakistan
 2021-01-01 PHASE4
NCT04687111 UNKNOWN
Atrial Remodeling; Myocardial Dysfunction; Left Ventricular Remodeling; Left Ventricular Diastolic Dysfunction; Hypertension; Cardiovascular Morbidity; Fibrosis Myocardial; Inflammatory Myopathy; Atrial Arrhythmia
Mark Ledwidge
 2015-12-16 PHASE2
NCT04800081 UNKNOWN
Hypertension
LanZhou University
 2020-07-09
NCT03917459 COMPLETED
Heart Failure; Heart Failure, Systolic; Erectile Dysfunction
Novartis Pharmaceuticals
 2019-04-16 PHASE3
NCT04688294 COMPLETED
Heart Failure
Amir Safwat
 2020-01-01 PHASE4
NCT04342351 UNKNOWN
Myocardial Infarction
RenJi Hospital
 2020-05-01 PHASE4
NCT02924727 COMPLETED
Acute Myocardial Infarction
Novartis Pharmaceuticals
 2016-12-09 PHASE3
NCT03791723 UNKNOWN
Atrial Fibrillation; Cardiac Remodeling, Atrial; Sacubitril/Valsartan
The Second Affiliated Hospital of Chongqing Medical University
 2019-06-01
NCT04458285 UNKNOWN
Hemodialysis Complication; Heart Failure
Guangdong Provincial People's Hospital
 2020-01-01
NCT04575675 COMPLETED
Hypotension; Heart Failure
Cheng-Hsin General Hospital
 2020-05-29 PHASE4
NCT02816736 COMPLETED
Heart Failure
Duke University
 2017-03-02 PHASE4
NCT03190304 COMPLETED
Heart Failure; Exercise Tolerance; Vasodilation; Body Composition; Muscle Strength
University of Sao Paulo General Hospital
 2017-06-14 PHASE4
NCT04206865 WITHDRAWN
Cardiogenic Shock
The Cleveland Clinic
 2019-11-25 PHASE4
NCT04092309 UNKNOWN
Hematopoietic Stem Cell Transplantation; Cardiotoxicity
University of Athens
 2019-09-20
NCT03552575 COMPLETED
Heart Failure
NHS Greater Glasgow and Clyde
 2018-07-01 PHASE3
NCT02916160 COMPLETED
Chronic Heart Failure; Sleep Apnea Syndrome
University Hospital, Montpellier
 2016-09-22 PHASE4
NCT04128891 WITHDRAWN
Heart Failure With Preserved Ejection Fraction
Flinders University
 2020-02-01 PHASE3
NCT03005184 WITHDRAWN
Heart Failure NYHA Class I; Heart Failure NYHA Class II; Heart Failure NYHA Class III
Vanderbilt University Medical Center
 2017-09 PHASE2
NCT02768298 COMPLETED
Chronic Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-07-12 PHASE4
NCT03909295 TERMINATED
Heart Failure With Preserved Ejection Fraction (HFpEF)
Novartis Pharmaceuticals
 2019-05-07 PHASE3
NCT03066804 COMPLETED
Heart Failure With Preserved Ejection Fraction
Novartis Pharmaceuticals
 2017-08-22 PHASE3
NCT03119623 WITHDRAWN
Heart Failure With Reduced Ejection Fraction
Brigham and Women's Hospital
 2017-06-01 PHASE4
NCT03872778 Recruiting
Neoplasms
Advanced Accelerator Applications
 2019-07-24 Phase 1|Phase 2
NCT01920711 COMPLETED
Heart Failure With Preserved Ejection Fraction
Novartis Pharmaceuticals
 2014-07-18 PHASE3
NCT03771729 UNKNOWN
CKD
The Second Affiliated Hospital of Harbin Medical University
 2018-12-30 EARLY_PHASE1
NCT02468232 COMPLETED
Heart Failure With Reduced Ejection Fraction (HF-rEF)
Novartis Pharmaceuticals
 2015-06-15 PHASE3
NCT02874794 COMPLETED
Heart Failure and Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-08-17 PHASE4
NCT02788656 TERMINATED
Congestive Heart Failure
Brigham and Women's Hospital
 2016-09 PHASE4
NCT02636283 TERMINATED
Peripheral Arterial Disease
University of Minnesota
 2017-12-31 PHASE2
NCT03279861 WITHDRAWN
Congestive Heart Failure; Hypertension
University of Maryland, Baltimore
 2017-11 PHASE4
NCT02887183 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2016-10-25 PHASE4
NCT03415906 WITHDRAWN
Heart Failure
Hannover Medical School
 2017-12-14 PHASE2
NCT02554890 COMPLETED
Acute Heart Failure
Novartis Pharmaceuticals
 2016-04-29 PHASE4
NCT02900378 COMPLETED
Chronic Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-12-20 PHASE3
NCT02970669 COMPLETED
Heart Failure, Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-12-16 PHASE4
NCT02661217 COMPLETED
Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-02-12 PHASE4
NCT02687932 COMPLETED
Mitral Valve Insufficiency; Left Ventricular Dysfunction
Asan Medical Center
 2016-03 PHASE4
NCT02226120 COMPLETED
Chronic Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2014-10-16 PHASE3
NCT02690974 COMPLETED
Hearth Failure With Reduced Ejection Fraction (HFrEF)
Novartis Pharmaceuticals
 2016-03-08 PHASE4
NCT04107220 UNKNOWN
Heart Failure
Unity Health Toronto
 2016-06
NCT02690974 Completed
Hearth Failure With Reduced Ejection Fraction (HFrEF)
Novartis Pharmaceuticals|Novartis
 2016-03-08 Phase 4
NCT02661217 Completed
Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals|Novartis
 2016-02-12 Phase 4
NCT01870739 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2013-10 PHASE2
NCT01692301 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2012-12 PHASE2
NCT01865188 WITHDRAWN
Hypertension
Novartis Pharmaceuticals
 2014-04 PHASE3
NCT02226120 Completed
Chronic Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals|Novartis
 2014-10-16 Phase 3
NCT01922089 COMPLETED
Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2013-11 PHASE2
NCT01785472 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
 2013-04 PHASE3
NCT01569815 COMPLETED
Mild and Moderate Renal Impairment
Novartis Pharmaceuticals
 2009-02 PHASE1
NCT01876368 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2013-09 PHASE3
NCT01035255 TERMINATED
Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2009-12 PHASE3
NCT01681576 COMPLETED
Salt-sensitive Hypertension
Novartis Pharmaceuticals
 2012-08 PHASE2
NCT01631864 COMPLETED
Hypertension; Concurrent Obesity
Novartis Pharmaceuticals
 2012-10 PHASE2
NCT01615198 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
 2012-08 PHASE3
NCT01663233 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
 2012-08 PHASE3
NCT01599104 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
 2012-06 PHASE3
NCT01593787 COMPLETED
Hypertension With Renal Dysfunction
Novartis Pharmaceuticals
 2012-05 PHASE3
NCT01646671 COMPLETED
Severe Hypertension
Novartis Pharmaceuticals
 2012-07 PHASE3
NCT01621633 COMPLETED
Hepatic Impairment
Novartis Pharmaceuticals
 2012-09 PHASE2
NCT01601470 COMPLETED
Mild to Moderate Hypertension
Novartis Pharmaceuticals
 2012-09 PHASE2
NCT01353508 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2011-03 PHASE2
NCT01256411 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
 2010-11 PHASE2
NCT00887588 COMPLETED
Chronic Heart Failure
Novartis Pharmaceuticals
 2009-11 PHASE2
NCT01281306 COMPLETED
Systolic Hypertension
Novartis Pharmaceuticals
 2011-01 PHASE2
NCT01193101 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2010-08 PHASE2
NCT01569828 COMPLETED
Pharmacokinetics; Renal Impaired; Healthy Volunteer
Novartis Pharmaceuticals
 2009-03 PHASE2
NCT00913653 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2009-05 PHASE2
NCT00549770 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2007-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the Sacubitril/valsartan (LCZ696) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sacubitril/valsartan (LCZ696) functions as a dual angiotensin receptor-neprilysin inhibitor, wherein the active metabolite of sacubitril inhibits neprilysin to prevent natriuretic peptide degradation while valsartan selectively blocks the angiotensin II type-1 receptor. This simultaneous target engagement enhances cyclic GMP signaling and suppresses renin-angiotensin-aldosterone axis activation, leading to systemic vasodilation, natriuresis, and reduced vascular resistance relevant to the clinical management of heart failure and hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.