Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)

NCT00239590 | Completed Phase 2 Results

• 1 other identifier: 2000AE13B
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Myocardial Perfusion

  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.

  Testosterone versus placebo (8 week treatment period)

Secondary Outcomes (1)

• Endothelial Function

  Testosterone versus placebo (8 week treatment period)

Study Arms (2)

Testosterone

EXPERIMENTAL

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

Drug: Testosterone undecanoate

Placebo

PLACEBO COMPARATOR

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

Drug: Testosterone undecanoate

Interventions

Testosterone undecanoate DRUG

Licensed for androgen deficiency

Also known as: Andriol, Org 538

Placebo; Testosterone

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Organon: collaborator

Study Sites (1)

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 18308009 RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr Carolyn Webb
• Organization: Imperial College London

c.webb@imperial.ac.uk

03301288860

Study Officials

• Peter Collins, MA MD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy dispensing of study medication that was randomized by supplier
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: June 1, 2001
• Primary Completion: April 24, 2004
• Study Completion: April 24, 2004
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-09

Locations

GB (1)