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

Heart Failure Clinical Trial

Official 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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arrhythmia
• Heart Failure

• NCT number: NCT03658174
• Study type: Interventional
• Source: University of Leicester
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Completion date: December 31, 2020