Nitrite in Hypertrophic Cardiomyopathy (HCM) Study
Research type
Research Study
Full title
Mechanistic study of the effect of inorganic sodium nitrate on cardiac and skeletal muscle metabolic efficiency in patients with hypertrophic cardiomyopathy.
IRAS ID
201323
Contact name
Michael Frenneaux
Contact email
Sponsor organisation
University of East Anglia
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
Nitrite has been shown to increase the efficiency in which skeletal muscle uses energy sources in the body. It is not known however, whether this also occurs in muscle in the heart. This study is designed to define whether nitrite improves energetic function of the heart in patients with hypertrophic cardiomyopathy (a heart condition characterised by energetic dysfunction). The study will comprise two visits that are two weeks apart. Participants will take inorganic sodium nitrate (to increase their nitrite levels) and a matching placebo tablet over the two visits: they will be randomised to either inorganic sodium nitrate or placebo on the first visit, with the other tablet to be taken on the second visit. Magnetic resonance imaging (MRI) and transthoracic echocardiography (TTE) will be used to assess heart function on both visits, so that function after taking the placebo can be compared to function after taking the inorganic sodium nitrate in the same patient.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0161
Date of REC Opinion
13 May 2016
REC opinion
Further Information Favourable Opinion