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Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)

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ClinicalTrials.gov Identifier: NCT00239590
Recruitment Status : Completed
First Posted : October 17, 2005
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Organon
Information provided by (Responsible Party):
Imperial College London

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Primary Purpose: Treatment
Official Title: Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease
Actual Study Start Date : June 2001
Actual Primary Completion Date : April 24, 2004
Actual Study Completion Date : April 24, 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Testosterone
oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks
 Drug: Testosterone undecanoate
Licensed for androgen deficiency
Other Names:
  • Andriol
  • Org 538
Placebo Comparator: Placebo
identical to active medication, taken in an identical way to the active arm
 Drug: Testosterone undecanoate
Licensed for androgen deficiency
Other Names:
  • Andriol
  • Org 538


Outcome Measures
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Primary Outcome Measures :
  1. Myocardial Perfusion [ Time Frame: Testosterone versus placebo (8 week treatment period) ]

    Myocardial perfusion (blood flow in the heart muscle) in subendocardial myocardial segments (one of the inner layers of heart muscle), supplied by coronary arteries without significant obstruction. This was measured using Cardiovascular Magnetic Resonance (CMR) imaging and a dual-bolus gadnolinium infusion protocol.

    Myocardial perfusion index = the ratio between myocardial perfusion measurements following adenosine-induced stress and rest measurements.



Secondary Outcome Measures :
  1. Endothelial Function [ Time Frame: Testosterone versus placebo (8 week treatment period) ]
    The endothelium is a single layer of cells that line all blood vessels and regulates arterial function. Coronary artery disease causes dysfunction of the endothelium but some substances/drugs help to reverse this dysfunction. In this study, endothelial function was measured by radial applanation tonometry which measures the blood pressure waveform during each cardiac cycle (heart beat). Radial artery pulse recordings were acquired, with an averaged waveform generated from 20 sequential waveforms. Augmentation index (AIx) is derived from this averaged waveform, and is the ratio of the pulse pressure at the second systolic arterial pressure waveform peak to that of the first systolic peak. The change in AIx before and after salbutamol (400mcg) is a measure of endothelial function.


Eligibility Criteria
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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
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00239590


Locations
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United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Organon
Investigators
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Principal Investigator: Peter Collins, MA MD FRCP Imperial College London
More Information
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Publications of Results:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00239590    
Other Study ID Numbers: 2000AE13B
First Posted: October 17, 2005    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Methyltestosterone
Testosterone
 Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents