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

NCT03658174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK

    collaborator OTHER

  • Loughborough University

    collaborator OTHER

  • University Hospitals, Leicester

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Andre Ng, MBChB, PhD · University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658174 on ClinicalTrials.gov