The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients

• Status: Recruiting
• Trial end date: 2022-12-16
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on cardiac oxygen consumption and the efficiency of cardiac work in patients with NYHA II-III heart failure (HF) and reduced systolic function using 11C-acetate positron emission tomography (PET) and echocardiography.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion criteria:

• 40-80 years of age

• Chronic HF with reduced EF (left ventricle EF 25-35%) and NYHA class II-III symptoms.

• Systolic BP 110-160 mm Hg

• Optimal standard HF therapy according to European Society of Cardiology (ESC) guidelines at a stable dose for at least 4 weeks before the screening visit.

Exclusion criteria:

• Estimated glomerular filtration rate (eGFR) < 45 ml/min

• Serum potassium > 5.2 mmol/l and creatinine >1.5 x ULN