168
Participants
Start Date
May 3, 2019
Primary Completion Date
May 15, 2022
Study Completion Date
June 30, 2022
Lifestyle
A 4-month lifestyle intervention will consist of two integrated components i.e. physical activity and dietary supplementation with inorganic nitrate. The physical activity component aims to increase daily physical activity level by at least 2000 steps/day from baseline (e.g. walking for approximately 30 minutes), at least 5-7 days per week. The second component of the lifestyle intervention is a dietary supplementation with inorganic nitrate. A single dose of inorganic nitrate given in the form of concentrated nitrate-rich beetroot juice (NO3-, BEET IT Sport, James White Drinks Ltd., Ipswich, UK) containing 6 mmol of NO3- in 70 ml bottle.
Sacubitril/Valsartan
Angiotensin receptor neprilysin inhibitor Sacubitril / Valsartan: The treatment period begins on day 1 with initial dosing of sacubitril/valsartan, followed by uptitration every 2 to 4 weeks to the target dose of 97/103 mg twice daily. 3 doses of sacubitril/valsartan available throughout the study are 24/26 mg, 49/51 mg, and 97/103 mg, each taken by mouth twice daily. If the patient discontinues the study medication, the patient is advised to return to the clinic for an end-of-study visit. Patients undergo treatment for 4 months.
University Hospital Regensburg, Regensburg
Azienda Ospedaliero Universitaria Careggi Florence, Florence
University of Belgrade Faculty of Medicine, Belgrade
Institute of Cardiovascular Diseases of Vojvodina, Kamenitz
Newcastle University, Faculty of Medical Sciences, Clinical Research Facility, Royal Victoria Infirmary; Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
Azienda Ospedaliero-Universitaria Careggi
OTHER
University Hospital Regensburg
OTHER
Institute of Cardiovascular Diseases, Vojvodina
OTHER
University of Belgrade
OTHER
Newcastle University
OTHER