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Randomized Controlled Trial
. 2016 Mar;27(2):95-103.
doi: 10.1097/MCA.0000000000000321.

The Cardiovascular Trial of the Testosterone Trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis

Moshrik Abd Alamir  1 , Susan S Ellenberg, Ronald S Swerdloff, Nanette K Wenger, Emile R Mohler 3rd, Cora E Lewis, Elizabeth Barrett-Conner, Rine Nakanishi, Sirous Darabian, Anas Alani, Suguru Matsumoto, Negin Nezarat, Peter J Snyder, Matthew J Budoff
Affiliations
Randomized Controlled Trial

The Cardiovascular Trial of the Testosterone Trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis

Moshrik Abd Alamir et al. Coron Artery Dis. 2016 Mar.

Abstract

Background: Data from prior studies have yielded inconsistent results on the association of serum testosterone levels with the risk for cardiovascular disease. There are no clinical trial data on the effects of testosterone replacement therapy on plaque progression.

Objective: We designed a study to investigate the effect of testosterone therapy on coronary artery plaque progression using serial coronary computed tomographic angiography (CCTA). In this paper, we describe the study design, methods, and characteristics of the study population.

Methods: The Cardiovascular Trial of the Testosterone Trials (TTrials; NCT00799617) is a double-blind, placebo-controlled trial of 1 year of testosterone therapy in men 65 years or older with clinical manifestations of androgen deficiency and unequivocally low serum testosterone concentrations (<275 ng/dl). CCTA performed at baseline and after 12 months of therapy will determine the effects of testosterone on the progression of the total volume of noncalcified plaques. All scans are evaluated at a central reading center by an investigator blinded to treatment assignment.

Results: A total of 165 men were enrolled. The average age is 71.1 years, and the average BMI is 30.7. About 9% of men had a history of myocardial infarction, 6% angina, and 10% coronary artery revascularization. A majority reported hypertension and/or high cholesterol; 31.8% reported diabetes. Total noncalcified plaque at baseline showed a slight but nonsignificant trend toward lower plaque volume with higher serum testosterone concentrations (P=0.12).

Conclusion: The Cardiovascular Trial will test the hypothesis that testosterone therapy inhibits coronary plaque progression, as assessed by serial CCTA.

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Conflict of interest statement

Conflict of Interest Reporting

SSE reports a conference grant from AbbVie during the conduct of the study; RSS reports grants and consulting from AbbVie, Clarus, Ardana, Besins Health, and Endo Pharma; CEL was supported by the National Institute for Diabetes, Digestive and Kidney Diseases, National Institutes of Health (DK079626) to the UAB Diabetes Research and Training Center; PJS reports grants from NIH and AbbVie for the conduct of this study and has consulted for Watson Laboratories; MJB reports grants from NIH and grant support from General Electric

Figures

Figure 1
Figure 1
Cardiac computed tomography angiography image using QAngio CT Research Edition 2.1.2 software. A – Straightened multi-planar reformatted volume of the vessel with lumen border contours and vessel wall borders of the of the left main and proximal left anterior descending coronary artery segment. B – Transversal cross-section perpendicular to the centerlines of figure 1A. One arrow (→) points to the contrast at the lumen of the vessel and the other arrow (←) points to a mixed plaque with calcified and no calcified composition. C – Axial cross-section demonstrating the left main and the proximal left anterior descending coronary artery segment.
Figure 2
Figure 2
Association of serum testosterone with noncalcified plaque volume in men participating in the Cardiovascular Trial of the Testosterone Trials.
See this image and copyright information in PMC

References

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