Status:
COMPLETED
Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Organon
Conditions:
Coronary Heart Disease
Eligibility:
MALE
35-75 years
Phase:
PHASE2
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 rec...
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 qua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2004
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00239590
Start Date
June 1 2001
End Date
April 24 2004
Last Update
September 25 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP