Lifestyle and Pharmacological Interventions in Hypertrophic Cardiomyopathy
Status:
Completed
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
The overall aim of this project is to establish potential benefits of a novel lifestyle
(physical activity and dietary nitrate) and pharmacological (angiotensin receptor neprilysin
inhibitor) interventions in patients with hypertrophic cardiomyopathy (HCM). HCM is the most
common genetic cardiovascular disease with a broad spectrum of disease severity. Angiotensin
receptor neprilysin inhibitor reduces death, hospitalisation, and may improve cardiac
function and exercise tolerance in heart failure. Exercise training is associated with a
significant increase in exercise tolerance, but appear to have limited effect on measures of
cardiac morphology or function in patients with HCM. Dietary supplementation with inorganic
nitrate (i.e. concentrated nitrate-rich beetroot juice) improves exercise capacity,
vasodilatation and cardiac output reserves while reduces arterial wave reflections, which are
linked to left ventricular diastolic dysfunction and remodelling. Using a five-centre, open
label, three-arm, pilot design, the present study will evaluate the effect of lifestyle
(physical activity and dietary supplementation with inorganic nitrate) and pharmacological
(angiotensin receptor neprilysin inhibitor sacubitril / valsartan) interventions in patients
with HCM. The Aim is to examine whether these interventions improve functional capacity,
clinical phenotypic characteristics, and quality of life in patients with HCM.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators:
Assistance Publique - Hôpitaux de Paris Azienda Ospedaliero-Universitaria Careggi Institute for Cardiovascular Diseases of Vojvodina University Hospital Regensburg