Angina Pectoris, Metabolic Syndrome X
Conditions
Keywords
Angina pectoris, Metabolic syndrome, Ischaemic heart disease
Brief summary
We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects who do not have overt diabetes. The drug will be given for 3 months and the subjects will be have their angina tested, by way of exercise testing, angina quality of life questionnaire and 24-hour ECG monitoring before and after using the drug.
Detailed description
Chronic stable angina is a common manifestation of ischaemic heart disease. Current mechanical therapies (percutaneous coronary intervention and coronary artery bypass grafting) and pharmacological therapies (nitrates, calcium channel blockers, betablockers and potassium channel activators) main actions are to treat the end product of ischaemic heart disease on chronic stable angina, i.e. the flow limiting stenosis. We postulate that by treating insulin resistance, an upstream factor in the pathogenesis of ischaemic heart disease, we will improve angina by in turn improving endothelial function. We will attempt to demonstrate this by way of full bruce protocol exercise tolerance test, Seattle Angina Questionnaire and 24 hour ST segment analysis before and after treatment with the insulin sensitiser rosiglitazone for three months.
Interventions
DRUGRosiglitazone
Sponsors
British Heart Foundation
GlaxoSmithKline
University of Glasgow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic stable angina - to see if this improves * Previous positive exercise tolerance test - to ensure that repeating it yields a result * Disease not suitable for coronary intervention (Coronary artery bypass grafting or angioplasty) - so that best routine care is not withheld * Do not have overt diabetes - work on this is being undertaken elsewhere * Body mass index (BMI) greater than 25
Exclusion criteria
* Diabetes mellitus - see above * Liver failure (ALT\>70U/l, AST\>80U/l) * Renal failure (creatinine \> 130mmol/l) * Cardiac failure - rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac failure * Physical disability - if it precludes treadmill testing * Women of child bearing capacity * Breast feeding mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in angina status at three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in small vessel function at three months | — |
| Change in markers of haemostasis at three months | — |
| Change in pulse wave velocity at three months | — |
| Change in blood pressure at three months | — |
| Change in anthropometric status at three months | — |
| Change in biochemical markers of insulin resistance/metabolic syndrome at three months | — |
Countries
United Kingdom
Outcome results
None listed