CompletedPhase 2

LCZ696 in Advanced LV Hypertrophy and HFpEF

Russia61 participantsStarted 2019-05-31

Plain-language summary

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.

Who can participate

Age range40 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Age ≤ 18 years;
✕. Evidence of myocardial ischemia during stress echocardiography;
✕. 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.);
✕. NYHA classification I or decompensated heart failure at screening;
✕. Systolic blood pressure \< 110 mmHg or \> 180 mmHg;
✕. Diastolic blood pressure \< 40 mmHg or \> 100 mmHg;
✕. Anemia (Hb \< 100 g/l);

What they're measuring

Change in 6-minute walking distance (6MWD)

Timeframe: 24 weeks

Trial details

NCT IDNCT03928158

SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Heart Failure trials