CompletedPhase 2/3

Lifestyle and Pharmacological Interventions in Hypertrophic Cardiomyopathy

United Kingdom168 participantsStarted 2019-04-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed diagnosis of obstructive and/or non-obstructive hypertrophic cardiomyopathy. * Agreement to be a participant in the study protocol and willing/able to return for follow-up. * Able to provide written informed consent Exclusion Criteria: * Less than 3 months post septal reduction therapy (surgery or catheter based intervention) * Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms. * Resting blood pressure greater than 180/100 mm Hg. * Systolic blood pressure lower than 100 mmHg * Hypotensive response to exercise testing (≥20 mmHg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure ≥20 mmHg). * Use of angiotensin converting Enzyme inhibitors or angiotensin receptor blockers. * Resting left ventricular outflow tract gradient \> 50 mm Hg. * Left ventricular ejection fraction of less than 50% by echocardiography. * Implanted pacemaker or cardiodefibrilator in the last 3 months or scheduled. * Renal insufficiency with a glomerular filtration rate of less than 30 mL/min per 1.73m2. * Present or planned pregnancy. * Life expectancy less than 12 months. * Body mass index \>40 kg/m2. * A history of exercise induced syncope or ventricular arrhythmias. * Inability to exercise due to orthopaedic or other non-cardiovascular limitations. * Use of other investigational…

What they're measuring

Peak Oxygen Consumption (ml/kg/min)

Timeframe: 4 months

Trial details

NCT IDNCT05366101

SponsorNewcastle-upon-Tyne Hospitals NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-28