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Author Notes:

Address for correspondence: Matthew J. Budoff, MD FACC, Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, California, Tel: +1-310 2224107, Fax: +1-3107829652, Email: mbudoff@labiomed.org

Author Disclosure: 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

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Research Funding:

Supported by the National Institutes of Health grant U01 AG030644 and AbbVie; R01 AG037679 (Bone Trial); T32-DK007571; 5-U01-AG030644, Subaward No. 558836; UAB Diabetes Research and Training Center (DRCT), Grant Number DK-079626 from the National Institute for Diabetes, Digestive and Kidney Diseases, National Institutes of Health; Funding for Rancho Bernardo Study has been supported by National Institutes of Health/National Institute on Aging grants AG07181 and AG028507 and the National Institute of Diabetes and Digestive and Kidney Diseases, grant DK31801

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • cardiovascular disease
  • coronary artery plaque progression
  • coronary computed tomographic angiography
  • randomized controlled trial
  • testosterone
  • ENDOGENOUS SEX-HORMONES
  • HEART-RATE-VARIABILITY
  • INTRAVASCULAR ULTRASOUND
  • ARTERY-DISEASE
  • MYOCARDIAL-INFARCTION
  • DIAGNOSTIC-ACCURACY
  • CT ANGIOGRAPHY
  • OLDER MEN
  • PLAQUE
  • THERAPY

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

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Journal Title:

Coronary Artery Disease

Volume:

Volume 27, Number 2

Publisher:

, Pages 95-103

Type of Work:

Article | Post-print: After Peer Review

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, placebocontrolled 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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