Testosterone and Myocardial Perfusion in CHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239590
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : March 26, 2015
Information provided by:
Imperial College London

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Testosterone undecanoate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease
Study Start Date : June 2001
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Myocardial perfusion measured using Cardiovascular Magnetic Resonance (CMR)

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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-CABG and PTCA
  • 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 AICD
  • Implanted ferromagnetic arterial clips
  • Left ventricular hypertrophy
  • NYHA III or IV
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239590

United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Principal Investigator: Peter Collins, MA MD FRCP Imperial College London Identifier: NCT00239590     History of Changes
Other Study ID Numbers: 2000AE13B
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: October 2005

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents