UNTRAP
Research type
Research Study
Full title
Upregulating the Nitric oxide pathway To Restore Autonomic Phenotype (UNTRAP). A double blind randomised first “proof of concept” direct translational study to explore the effects of dietary nitrate supplementation on autonomic function in heart failure patients.
IRAS ID
245395
Contact name
Michelle Muessel
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
1 years, 5 months, 18 days
Research summary
Research Summary
Autonomic nervous system dysfunction is known to be associated with an increased risk of heart rhythm abnormalities and sudden cardiac death (SCD) in patients with chronic heart failure - a condition affecting millions of people worldwide. The nitric oxide pathway has been identified as being involved in mediating the effects of the autonomic nervous system on the heart. Recent studies have shown that dietary nitrates can increase the availability of nitric oxide in the body. This pilot double blind placebo controlled crossover study hopes to find out if dietary nitrate supplementation can help to improve cardiac and autonomic function in patients with heart failure and autonomic dysfunction.We will invite 20 patients from the University Hospitals of Leicester NHS Trust to take a beetroot juice supplement, which naturally contains a high concentration of nitrates, and a nitrate-free (placebo) beetroot supplement to see the effects the nitrates may have on cardiac health.
The patients will be divided randomly into 2 study groups; group 1 will take the nitrate-rich beetroot juice for the first 4 weeks. They will then have a ‘washout’ period with no treatment for 4 weeks, followed by the placebo nitrate-free beetroot juice for 8 weeks. Patients in group 2 will receive the placebo juice for the first 4 weeks, will then have a ‘washout’ period with no treatment for 4 weeks, and then have the nitrate-rich beetroot juice for 8 weeks.
In order to assess cardiac and autonomic function, and risk of heart rhythm abnormalities, the following tests will be carried out before and after the treatment: echocardiography scan, cardiopulmonary exercise test, 24 hour ambulatory ECG monitor, blood tests and questionnaire. Patients will only be in the study for 16 weeks - no long-term follow-up is required.
Summary of Results
The UNTRAP study was able to recruit 24 patients. Out of these 2 patients failed screening and a further 2 patients withdraw consent prior to starting the study. Therefore a total of 20 patients took part in the study. 3 patients were lost to follow-up and 17 patients completed all study visits.
The beetroot juice supplement used as the study treatment was found to be safe and well tolerated with few side effects reported. No treatment related adverse events were reported.
Analysis of blood samples showed a significant increase in nitrate and nitrite levels with nitrate rich beetroot juice, compared to placebo beetroot juice.
Full analysis of the primary and secondary outcome measures is still ongoing and will be published in due course.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0218
Date of REC Opinion
9 Aug 2018
REC opinion
Further Information Favourable Opinion