Upregulating the Nitric Oxide Pathway To Restore Autonomic Phenotype (UNTRAP). (UNTRAP)
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|ClinicalTrials.gov Identifier: NCT03658174|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Arrhythmia||Dietary Supplement: Nitrate-rich beetroot juice Dietary Supplement: Nitrate-free beetroot juice||Not Applicable|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Double blind placebo controlled crossover study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||February 21, 2020|
|Estimated Study Completion Date :||February 21, 2020|
Active Comparator: Nitrate-rich beetroot juice
70mls of concentrated beetroot juice to be taken twice a day. This contains 5-6 mmol of inorganic nitrate.
Dietary Supplement: Nitrate-rich beetroot juice
70mls of concentrated beetroot juice containing approximately 5-6 mmol of inorganic nitrate
Placebo Comparator: Nitrate-free beetroot juice
70mls of concentrated nitrate-free beetroot juice to be taken twice a day. This is an identical juice from which the nitrate has been removed using a standard anion exchange resin.
Dietary Supplement: Nitrate-free beetroot juice
70mls of concentrated beetroot juice that has been nitrate-depleted
Other Name: placebo
- Change in heart rate variability (HRV) from baseline [ Time Frame: 4 weeks and 8 weeks ]Measure of autonomic function
- Change in QT variability index (QTVI) from baseline [ Time Frame: 4 weeks and 8 weeks ]Marker of arrhythmia risk
- Change in Regional Restitution Instability Index (R2I2) from baseline [ Time Frame: 4 weeks and 8 weeks ]Marker of ventricular arrhythmia and sudden cardiac death risk
- Change in Peak Electrocardiogram Restitution Slope (PERS) from baseline [ Time Frame: 4 weeks and 8 weeks ]Marker of ventricular arrhythmia and sudden cardiac death risk
- Change in left ventricular function from baseline [ Time Frame: 4 weeks and 8 weeks ]LVEF, volumes and filling pressure (E/e ratio)
- Change in peak oxygen uptake (VO2max) on cardiopulmonary exercise test from baseline [ Time Frame: 4 weeks and 8 weeks ]Maximum oxygen uptake
- Change in total exercise time on cardiopulmonary exercise test from baseline [ Time Frame: 4 weeks and 8 weeks ]Time to exhaustion on exercise test
- Change in the total score on the Minnesota Living With Heart Failure Quality of Life Questionnaire from baseline [ 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
- Participant compliance with dietary supplement [ Time Frame: 4 weeks and 8 weeks ]Compliance as measured using supplement and food diary
- Correlation between Non-Invasive Programmed Stimulation (NIPS) derived and exercise ECG derived R2I2 and PERS values [ Time Frame: 4 weeks ]Assessment of the correlation between R2I2 and PERS values recorded using NIPS and exercise ECG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658174
|Contact: Zakariyya Vali, MBChB, MRCP||+44(0)email@example.com|
|Contact: Andre Ng, MBChB, PhD||+44(0)firstname.lastname@example.org|
|Glenfield Hospital, University Hospitals of Leicester NHS Trust||Recruiting|
|Leicester, Leicestershire, United Kingdom, LE3 9QP|
|Contact: Zakariyya Vali, MBChB +44(0)1162583297 email@example.com|
|Principal Investigator:||Andre Ng, MBChB, PhD||University of Leicester|