Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy

PHASE2CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

May 3, 2019

Primary Completion Date

May 15, 2022

Study Completion Date

June 30, 2022

Conditions
Hypertrophic Cardiomyopathy
Interventions
BEHAVIORAL

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.

DRUG

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.

Trial Locations (5)

Unknown

University Hospital Regensburg, Regensburg

Azienda Ospedaliero Universitaria Careggi Florence, Florence

University of Belgrade Faculty of Medicine, Belgrade

Institute of Cardiovascular Diseases of Vojvodina, Kamenitz

NE2

Newcastle University, Faculty of Medical Sciences, Clinical Research Facility, Royal Victoria Infirmary; Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

All Listed Sponsors
collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

collaborator

University Hospital Regensburg

OTHER

collaborator

Institute of Cardiovascular Diseases, Vojvodina

OTHER

collaborator

University of Belgrade

OTHER

lead

Newcastle University

OTHER

NCT03832660 - Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy | Biotech Hunter | Biotech Hunter