Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The main purpose of this project is to determine whether testosterone treatment over a number
      of weeks can beneficially affect myocardial perfusion, vascular reactivity, metabolic risk
      factors and quality of life in men with documented coronary heart disease. Men with
      documented significant coronary artery disease and a positive exercise test for myocardial
      ischaemia will be enrolled into the study. They will be randomised to active testosterone
      therapy (5 mg/day) or placebo for 2 months. After 2 months they will undergo MRI perfusion
      scanning, radial artery applanation tonometry to assess endothelial function, blood sampling
      for analysis of metabolic risk factors for coronary heart disease, complete quality of life
      questionnaires and will cross-over to the opposite treatment. After a further 2 month period
      these tests will be repeated. Angina diaries will be kept for the duration of the study.
    

Intervention name(s): Testosterone undecanoate
Intervention type(s): Drug
Intervention description(s): Licensed for androgen deficiency
Other intervention name(s): Andriol; Org 538
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment