Rosiglitazone Versus Placebo in Chronic Stable Angina

Study Overview
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Brief Summary
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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
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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.

Official Title
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Insulin Sensitisation as a Novel Mechanism to Lessen Ischaemic Burden in Overweight Non-Diabetic Patients With Chronic Stable Angina: A Pilot Study

Conditions
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Angina Pectoris, Metabolic Syndrome X

Intervention / Treatment
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* Drug: Rosiglitazone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosiglitazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in angina status at three months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pulse wave velocity at three months |  |  | 
| Change in small vessel function at three months |  |  | 
| Change in markers of haemostasis at three months |  |  | 
| Change in biochemical markers of insulin resistance/metabolic syndrome at three months |  |  | 
| Change in blood pressure at three months |  |  | 
| Change in anthropometric status at three months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angina pectoris, Metabolic syndrome, Ischaemic heart disease