At a glance
ClinicalIndex Comparison Record- ✓Men aged 35 to 75 years
- ✓Angiographically proven coronary artery disease (≥70% lesion in at least one major coronary artery or major branch), including post-CABG and post-PCI patients
- ✓Plasma testosterone ≤12 nmol/L
- ✓Normal prostate specific antigen (PSA; normal range 0–4 ng/mL)
- ✕Significant arrhythmia, particularly those affecting ST-segment interpretation on ECG
- ✕Current treatment with testosterone or similar hormonal therapy
- ✕Thoracic or abdominal surgery within the previous 3 months
- ✕Haemoglobin >16 g/dL or haematocrit >50%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease
In Brief
A Phase 2 clinical trial evaluating Testosterone undecanoate for Coronary Heart Disease. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Testosterone has traditionally been regarded as a risk factor for heart disease due to the fact that males have a higher incidence of this disease than women, at least until the menopause. However recent studies have shown that men with low levels of testosterone may be at an increased risk of developing coronary heart disease (furring up of the blood vessels supplying blood to the heart). Our group has demonstrated a relaxing effect of testosterone in isolated animal coronary arteries (blood vessels supplying blood to the heart). We have shown that short-term testosterone administration can increase coronary artery and brachial artery (blood vessel in the arm) blood flow and can decrease the lack of blood supply to the heart muscle in men with coronary artery disease. These findings indicate a need for similar but longer-term studies to investigate the possible beneficial effects of longer-term testosterone therapy on the heart and blood vessels. Should this treatment be shown to be beneficial to men with coronary artery disease it may be a useful additional therapy for men with the furring up of arteries in the heart and the resulting angina. Aim To investigate our hypothesis that testosterone can beneficially affect myocardial perfusion, vascular reactivity, metabolic risk factors for coronary heart disease and improve quality of life in men with low plasma testosterone levels and coronary heart disease.
Study Details
Timeline
Interventions
Licensed for androgen deficiency