Testosterone and Myocardial Perfusion in CHD

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00239590
First received: October 13, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Heart Disease
Drug: Testosterone undecanoate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Imperial College London:

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

Study Start Date: June 2001
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men
  • Aged 35 to 75 years
  • Angiographically proven coronary artery disease (70 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%
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239590

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

No publications provided

ClinicalTrials.gov Identifier: NCT00239590     History of Changes
Other Study ID Numbers: 2000AE13B
Study First Received: October 13, 2005
Last Updated: October 13, 2005
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014