NCT03928158CompletedPhase 2
LCZ696 in Advanced LV Hypertrophy and HFpEF
Sacubitril/Valsartan (LCZ696) in Patients With Advanced Hypertensive Left Ventricular Hypertrophy and Heart Failure With Preserved Ejection Fraction: Clinical, Haemodynamic and Neurohumoral Effects (a Phase 2, Randomized, Single-center, Parallel Group Study)
Source: ClinicalTrials.gov · Last updated 25 May 2025
Brief summary (registry, in English)
Patients with advanced LVH and HFpEF will be randomly assigned in open-label fashion to receive LCZ696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily, and will be treated for 24 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 23 Apr 2019
- Start date
- 31 May 2019
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT03928158
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 61
- From 31 May 2019 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of myocardial ischemia during stress echocardiography;
- NYHA classification I or decompensated heart failure at screening;
- Significant left sided structural valve disease;
- Secondary hypertension;
- Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;
- Myocardial infarction or myocardial revascularization within the last 3 months of screening;
- Stroke or TIA within the last 3 months of screening;
- Autoimmunic and oncological diseases;
Lab values
- Anemia (Hb \< 100 g/l);
- Impaired renal function, defined as eGFR \< 30 ml/min/1.73 m²;
- Potassium concentration \>5.2 mmol/L.
Age
- Age ≤ 18 years;
Other
- Chronic atrial flutter or atrial fibrillation;
- Alternative cause of left ventricular hypertrophy and impaired diastolic function (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis and etc.);
- Systolic blood pressure \< 110 mmHg or \> 180 mmHg;
- Diastolic blood pressure \< 40 mmHg or \> 100 mmHg;
- Impaired liver function;
Who the study is looking for
- Moderate/severe hypertensive left ventricular (LV) hypertrophy (LVMi ≥109 g/m² in women and ≥132 g/m² in men);
- New York Heart Association (NYHA) class II-III heart failure;
- Left ventricular ejection fraction \> 50%;
- Increased LV filling pressures assessed at rest or at peak exercise by echocardiography
- Body mass index (BMI) \> 30 kg/m²
- Signed and data informed consent
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Research Center for Cardiology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.