Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE3 9QP, United Kingdom
NCT Number: NCT03658174
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Leicester, Leicestershire, LE3 9QP, United Kingdom
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-Invasive Programmed Stimulation (NIPS) Sub-Study Inclusion Criteria:
Exclusion criteria
70mls of concentrated beetroot juice containing approximately 5-6 mmol of inorganic nitrate
70mls of concentrated beetroot juice that has been nitrate-depleted
Other names: placebo
Time frame: 4 weeks and 8 weeks
Measure of autonomic function
Time frame: 4 weeks and 8 weeks
Marker of arrhythmia risk
Time frame: 4 weeks and 8 weeks
Marker of ventricular arrhythmia and sudden cardiac death risk
Time frame: 4 weeks and 8 weeks
Marker of ventricular arrhythmia and sudden cardiac death risk
Time frame: 4 weeks and 8 weeks
LVEF, volumes and filling pressure (E/e ratio)
Time frame: 4 weeks and 8 weeks
Maximum oxygen uptake
Time frame: 4 weeks and 8 weeks
Time to exhaustion on exercise test
Time frame: 4 weeks and 8 weeks
Measured using Minnesota Living With Heart Failure Quality of Life Questionnaire, with total score ranging from 0 to 105
Time frame: 4 weeks and 8 weeks
Compliance as measured using supplement and food diary
Time frame: 4 weeks
Assessment of the correlation between R2I2 and PERS values recorded using NIPS and exercise ECG
University of Leicester
Other
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
Acronym: UNTRAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00382525
Arrhythmia, Arrhythmia, Sinus
Braine-l'Alleud, Belgium
View Trial DetailsNCT01841242
Arrhythmia, Arrhythmias, Cardiac
Aix-en-Provence, France
View Trial DetailsNCT04096781
Arrhythmia, Arrhythmias, Cardiac
Palo Alto, California, United States
View Trial DetailsNCT01076348
Arrhythmia, Arrhythmias, Cardiac
Birmingham, Alabama, United States
View Trial Details