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. 2021 May 22;2021(5):CD012721. doi: 10.1002/14651858.CD012721.pub3

NCT03928158.

Study name LCZ696 in advanced LV hypertrophy and HFpEF
Methods Study design: parallel RCT
Anticipated completion date: November 2020
Participants Estimated enrolment: 60
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);

  • 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;

  • Impaired renal function, defined as eGFR < 30 ml/min/1.73 m²;

  • Impaired liver function;

  • Potassium concentration >5.2 mmol/L.
Interventions LCZ696 versus valsartan
24 weeks
Outcomes 6‐minute walking distance; exercise time during diastolic stress‐test; left atrial volume index (LAVI); average E/e' ratio; pulmonary artery systolic pressure (PASP); left ventricular mass index (LVMI); New York Heart Association (NYHA) functional classification; Minnesota Living With Heart Failure Questionnaire (MLHFQ) score; N‐terminal pro b‐type natriuretic peptide (NT‐proBNP); high‐sensitivity C‐reactive protein (hsCRP); carboxyterminal propeptide of type I collagen (PICP); carboxyterminal telopeptide of type I collagen (CITP); N‐Propeptide Of Type III Procollagen (PIIINP); Growth/differentiation factor 15 (GDF‐15); sST2; Galectin‐3; monocyte chemoattractant‐1 (MCP‐1)
Starting date 31 May 2019
Contact information Artem Ovchinnikov: artcardio@mail.ru
Notes