Nitrite in Hypertrophic Cardiomyopathy (HCM) Study

Summary

Inorganic nitrate, which is found at high levels in green leafy vegetables, is reduced to nitrite by bacteria in the mouth, swallowed, and absorbed in the stomach into the blood. Studies have shown that increasing the blood levels of nitrite improves the way that muscles use oxygen and energy during exercise, and potentially blood flow.

Some people (\~1 in 500) suffer from a type of genetic heart condition known as hypertrophic cardiomyopathy (HCM). This condition means that the muscle in the heart does not use energy well and becomes larger than average, meaning that they have to tap into the heart's 'energy reserves'. It is not known if nitrite has the same beneficial effects on heart muscle as on other muscles in the body. Our study will explore the mechanism by which nitrite may improve the function and energy status of the heart in HCM.

Conditions

• Cardiomyopathy, Hypertrophic

Interventions

DRUG

Sodium Nitrate

Single dose of 14mmol oral inorganic sodium nitrate

DRUG

Placebo

Single dose of oral matching placebo

DIAGNOSTIC_TEST

Phosphorous Magnetic Resonance Spectroscopy

On the first visit day of this arm, participants will be lie inside an MRI scanner to take pictures of the heart. The thigh muscle will then be imaged before, during, and after kicking exercises.

DIAGNOSTIC_TEST

Exercise Stress Transthoracic Echocardiogram

On the second visit day of this arm, participants will be asked to lie, semi-erect, on an exercise bed for up to 90 minutes. The echocardiogram will be performed at rest and during peak exercise. The exercise will be in the form of a pedal bike. The exercise levels will be worked out from an upright bicycle exercise test completed by the participants prior to randomization.

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• British Medical Research Council

  collaborator OTHER_GOV

• University of East Anglia

  lead OTHER

Principal Investigators

• Michael P Frenneaux, MD · University of East Anglia

• Sunil V Nair, MD · Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-30

Primary Completion

2018-12-31

Completion

2019-01-31

Countries

• United Kingdom

Study Locations