LCZ696 in Advanced LV Hypertrophy and HFpEF

• Status: Recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Collaborator: Ministry of Health of Russian Federation
• Treatments: Enalapril; Enalaprilat; LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

1. Moderate/severe hypertensive left ventricular (LV) hypertrophy (LVMi ≥109 g/m² in women and ≥132 g/m² in men);

2. New York Heart Association (NYHA) class II-III heart failure;

3. Left ventricular ejection fraction > 50%;

4. Increased LV filling pressures assessed at rest or at peak exercise by echocardiography

5. Body mass index (BMI) > 30 kg/m²

6. Signed and data informed consent

Exclusion Criteria:

1. Age ≤ 18 years;

2. Evidence of myocardial ischemia during stress echocardiography;

3. Chronic atrial flutter or atrial fibrillation;

4. Alternative cause of left ventricular hypertrophy and impaired diastolic function (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis and etc.);

5. NYHA classification I or decompensated heart failure at screening;

6. Systolic blood pressure < 110 mmHg or > 180 mmHg;

7. Diastolic blood pressure < 40 mmHg or > 100 mmHg;

8. Anemia (Hb < 100 g/l);

9. Significant left sided structural valve disease;

10. Secondary hypertension;

11. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;

12. Myocardial infarction or myocardial revascularization within the last 3 months of screening;

13. Stroke or TIA within the last 3 months of screening;

14. Autoimmunic and oncological diseases;

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

16. Impaired liver function;

17. Potassium concentration >5.2 mmol/L.