Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Testosterone undecanoate
Intervention description: Licensed for androgen deficiency
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Pharmacy dispensing of study medication that was randomized by supplier
Enrollment: 28.0
Sex: Male
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men

          -  Aged 35 to 75 years

          -  Angiographically proven coronary artery disease (70 percent lesion in at least one
             major coronary artery, or major branch), including patients post-coronary artery
             bypass graft (CABG) and percutaneous coronary intervention (PCI)

          -  Plasma testosterone less than or equal to 12 nmol/l

          -  Normal prostate specific antigen (PSA; normal range 0 - 4 g/l)

          -  Willing to give written informed consent

        Exclusion Criteria:

          -  Significant arrhythmia, particularly those which would affect interpretation of the
             ST-segment of the ECG

          -  Treatment with digitalis

          -  Treatment with testosterone or similar hormonal therapy

          -  Thoracic or abdominal surgery within the previous 3 months

          -  Haemoglobin >16 g/dL

          -  Haematocrit >50 percent

          -  History of hormone-dependent cancer such as prostate or breast cancer

          -  Hypercalcaemia

          -  Nephrosis

          -  Pacemaker or automated implantable cardiac defibrillator

          -  Implanted ferromagnetic arterial clips

          -  Left ventricular hypertrophy

          -  New York Heart Association (NYHA) III or IV functional class

          -  Intolerance of confined spaces

          -  Previous allergic reaction to Gadolinium

          -  Participation in another research study within the previous 60 days

          -  Unwilling to give written informed consent