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slow recruitment: stopped early
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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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Allopurinol is a drug commonly used to treat gout. However recent studies have shown it has the potential to help improve oxygen supply to heart muscle. In this study the Investigators aim to find out if allopurinol slows down the onset of angina symptoms, as seen by a doctor on a tracing of the heart (ECG- electrocardiogram), for patients who have been diagnosed with heart disease, when exercising on a treadmill. The Investigators are also are trying to figure out the best dose of allopurinol to use and to see how quickly it begins working. To do this the investigators will recruit patients with angina, exercise them on a treadmill after giving different doses of allopurinol and see if there is an improvement in their time to bring on angina symptoms and signs. Patients recruited to this trial will receive three different treatment regimes over a six week period. Each treatment regime will last for one week with a one week rest period between each regime. This will involve up to eleven visits to Ninewells Medical School, Dundee for testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol High dose | Experimental |
| |
| Allopurinol Low dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug | Stat dose Allopurinol 800mg, then 400mg BD for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in time to exercise induced ST depression | A continuous ECG tracing will be recorded. Time to >1mm change in ST measurements will be noted. Exercise Tolerance testing (ETT) 1 hour before study drug administration is baseline measurement. Comparisons will be made 4 hours, 1 day and 5 days after baseline ETT. | 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug |
| Measure | Description | Time Frame |
|---|---|---|
| change in total exercise time on Exercise Tolerance Testing (ETT) | A continuous ECG tracing will be recorded. Time to total exercise time, ie when patient can walk no further will be noted. Exercise Tolerance Testing (ETT) 1 hour before study drug administration is baseline measurement. Comparisons will be made 4 hours, 1 day and 5 days after baseline ETT. | 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Tayside | Dundee | Angus | DD1 9SY | United Kingdom |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Allopurinol |
| Drug |
Stat dose Allopurinol 400mg, then 300mg BD for 5 days |
|
| Placebo | Drug | Matched placebo, stat dose, then 5 days of matched placebo BD. |
|
| Change in time to subjects reported symptoms of chest pain during exercise testing. | A continuous ECG tracing will be recorded. Time to reported chest pain will be noted. Exercise Tolerance testing (ETT) 1 hour before study drug administration is baseline measurement. Comparisons will be made 4 hours, 1 day and 5 days after baseline ETT. | hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug |
| changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing | Baseline is pre 1st study drug dose exercise tolerance test (ETT). Comparisons will be made before and after 4 hour post drug ETT | Pre and post 4 hour ETT compared to baseline |
| angina pain and Glyceryl TriNitrate (GTN) usage | subjects will use angina log to record symptoms of angina and GTN usage between hospital visits | Weekly |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |