Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)

NCT ID: NCT00239590

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2004-04-24

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.

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Testosterone

oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks

Group Type: EXPERIMENTAL

Testosterone undecanoate

Intervention Type: DRUG

Licensed for androgen deficiency

Placebo

identical to active medication, taken in an identical way to the active arm

Group Type: PLACEBO_COMPARATOR

Testosterone undecanoate

Intervention Type: DRUG

Licensed for androgen deficiency

Interventions

Testosterone undecanoate

Licensed for androgen deficiency

Intervention Type: DRUG

Other Intervention Names

Andriol; Org 538

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Organon

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Collins, MA MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Royal Brompton & Harefield NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

Webb CM, Elkington AG, Kraidly MM, Keenan N, Pennell DJ, Collins P. Effects of oral testosterone treatment on myocardial perfusion and vascular function in men with low plasma testosterone and coronary heart disease. Am J Cardiol. 2008 Mar 1;101(5):618-24. doi: 10.1016/j.amjcard.2007.09.114. Epub 2007 Dec 21.

Reference Type: RESULT

PMID: 18308009 (View on PubMed)

Other Identifiers

2000AE13B

Identifier Type: -

Identifier Source: org_study_id