Controlled Trial on the Short-term Effects of Sacubitril/Valsartan Therapy on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Patients With NYHA II-III Heart Failure and Reduced Systolic Function Using 11C-acetate Positron Emission Tomography and Echocardiography
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Jul 05, 2018
Feb 28, 2021
40 Years - 75 Years (Adult, Older Adult)
sacubitril/valsatran 100 or 200 mg BID
Valsartan 80 or 160 mg BID
placebo to valsartan
placebo to valsartan 80 or 160 BID
placebo to sacubitril/valsartan
placebo to sacubitril/valsartan 100 or 200 mg BID
40-75 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.
Estimated glomerular filtration rate (eGFR) < 45 ml/min
Serum potassium > 5.2 mmol/l and creatinine >1.5 x ULN