NCT03658174

Upregulating the Nitric Oxide Pathway To Restore Autonomic Phenotype (UNTRAP).

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 and reduce the risk of arrhythmias.

Detailed description

20 participants enrolled at the University Hospitals of Leicester NHS Trust will be invited to take a beetroot juice supplement, which naturally contains a high concentration of nitrates, and a nitrate-free (placebo) beetroot supplement. In a double blind way, participants will be randomised to the order in which they receive the 2 treatments with crossover of the treatments. There will be a washout period between the two treatments. In order to assess cardiac and autonomic function, and risk of heart rhythm abnormalities, tests will be carried out before and after each treatment period Hypotheses: * Nitrate supplementation reverses the autonomic dysfunction seen in Chronic Heart Failure (CHF) * Markers of prognostic significance for predicting SCD, including QT variability index and cardiac restitution properties (R2I2, PERS), are normalised by nitrate supplementation in patients with CHF. * Nitrate supplementation results in functional improvement in CHF patients.

Conditions

• Heart Failure
• Arrhythmia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nitrate-rich beetroot juice	70mls of concentrated beetroot juice containing approximately 5-6 mmol of inorganic nitrate
DIETARY_SUPPLEMENT	Nitrate-free beetroot juice	70mls of concentrated beetroot juice that has been nitrate-depleted

Timeline

• Start date: 2018-08-30
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-09-05
• Last updated: 2021-05-03

Locations

1 site across 1 country: United Kingdom