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| ID | Type | Description | Link |
|---|---|---|---|
| Edge ID 108647 | Other Identifier | University Hospitals of Leicester NHS Trust |
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| Name | Class |
|---|---|
| National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK | OTHER |
| Loughborough University | OTHER |
| University Hospitals, Leicester | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate-rich beetroot juice | Active Comparator | 70mls of concentrated beetroot juice to be taken twice a day. This contains 5-6 mmol of inorganic nitrate. |
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| Nitrate-free beetroot juice | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrate-rich beetroot juice | Dietary Supplement | 70mls of concentrated beetroot juice containing approximately 5-6 mmol of inorganic nitrate |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate variability (HRV) from baseline | Measure of autonomic function | 4 weeks and 8 weeks |
| Change in QT variability index (QTVI) from baseline | Marker of arrhythmia risk | 4 weeks and 8 weeks |
| Change in Regional Restitution Instability Index (R2I2) from baseline | Marker of ventricular arrhythmia and sudden cardiac death risk | 4 weeks and 8 weeks |
| Change in Peak Electrocardiogram Restitution Slope (PERS) from baseline | Marker of ventricular arrhythmia and sudden cardiac death risk | 4 weeks and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular function from baseline | LVEF, volumes and filling pressure (E/e ratio) | 4 weeks and 8 weeks |
| Change in peak oxygen uptake (VO2max) on cardiopulmonary exercise test from baseline |
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Inclusion Criteria:
Non-Invasive Programmed Stimulation (NIPS) Sub-Study Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Ng, MBChB, PhD | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital, University Hospitals of Leicester NHS Trust | Leicester | Leicestershire | LE3 9QP | United Kingdom |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double blind placebo controlled crossover study
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| Nitrate-free beetroot juice | Dietary Supplement | 70mls of concentrated beetroot juice that has been nitrate-depleted |
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Maximum oxygen uptake
| 4 weeks and 8 weeks |
| Change in total exercise time on cardiopulmonary exercise test from baseline | Time to exhaustion on exercise test | 4 weeks and 8 weeks |
| Change in the total score on the Minnesota Living With Heart Failure Quality of Life Questionnaire from baseline | Measured using Minnesota Living With Heart Failure Quality of Life Questionnaire, with total score ranging from 0 to 105 | 4 weeks and 8 weeks |
| Participant compliance with dietary supplement | Compliance as measured using supplement and food diary | 4 weeks and 8 weeks |
| Correlation between Non-Invasive Programmed Stimulation (NIPS) derived and exercise ECG derived R2I2 and PERS values | Assessment of the correlation between R2I2 and PERS values recorded using NIPS and exercise ECG | 4 weeks |