Angina Pectoris Clinical Trial
Official title:
The Effect of Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
NCT number | NCT00131183 |
Other study ID # | STH13979 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2005 |
Est. completion date | May 2008 |
Verified date | September 2006 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to address the following questions on the effects of testosterone therapy in
men with coronary ischaemia:
- Does the anti-anginal effect persist long term? Many of the published studies are acute
single dose trials and none of the chronic studies have assessed patients formally
beyond a few months. The investigators' earlier studies were limited to 3 months.
- Does testosterone therapy in men affect the levels of measurable atheroma? There is
currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of
atheroma, although there is abundant evidence in animals to suggest a potential
improvement.
This study addresses the two issues and would be of one-year duration but would be the
longest trial of testosterone therapy in men with cardiovascular disease. The primary
endpoint is the change in time to ST- segment depression of > 1mm during exercise testing.
Status | Completed |
Enrollment | 15 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Males over 20 years of age - Stable, chronic angina pectoris for > 1 month - ST- segment depression of > 1mm within 12 minutes of the Bruce protocol - Willing and able to give informed consent and comply with the study protocol - Serum testosterone (< 12nmol/L) Exclusion Criteria: - Use of androgen therapy or anabolic steroids within 6 months of entry into the study (i.e. screening visit/visit 1) or concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone - Contraindication to treatment with Nebido®. - Organic hypothalamic-pituitary pathology - Prostate specific antigen (PSA) >= 4ng/ml - Severe symptomatic benign prostatic hyperplasia - Patients actively or potentially trying to start a family or requiring fertility treatment - Suspicion of, current, or past history of breast or prostatic carcinoma - Myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in the last three months. - Significant hepatic, respiratory, haematological or renal disease - Haematocrit > 50% at entry to the study (i.e. screening visit/visit 1) - History of significant arrhythmia, Wolff-Parkinson-White (WPW) syndrome, > 1st degree heart block, or cerebrovascular accident (CVA) within the last three months - History of drug or alcohol abuse - Receiving other trial drugs within 12 weeks - Hypotension (systolic blood pressure [BP] < 100 mm Hg) - Severe, malignant, complicated, renovascular, secondary, or uncontrolled hypertension (BP > 180/114) - Hypercalcaemia - Nephrotic range proteinuria - Symptomatic obstructive sleep apnoea syndrome - Electrocardiogram (ECG) abnormalities that preclude ST- segment analysis (eg left bundle branch block [LBBB], atrial fibrillation [AF]) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hallamshire Hospital | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust | Schering-Plough |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in time to ST- segment depression of > 1mm during exercise testing | |||
Secondary | Change in carotid atheroma assessed by media:intimal thickness ratio of the carotid artery | |||
Secondary | Change in time to exercise induced chest pain as judged by a single observer | |||
Secondary | Change in frequency of attacks of angina as recorded in the patients' angina diary | |||
Secondary | Change in high sensitivity C reactive protein (hs-CRP) | |||
Secondary | Change in scores on the Seattle Angina Questionnaire (SAQ) | |||
Secondary | Change in scores of quality of life (Euroquol) | |||
Secondary | Change in scores of depression using the Beck Depression Inventory |
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