title: 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.
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).
  
  
  CONCLUSIONS
  The Cardiovascular Trial will test the hypothesis that testosterone therapy inhibits coronary plaque progression, as assessed by serial CCTA.
authors.affiliation: aLos Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, California bCenter for Clinical Epidemiology & Biostatistics cDivision of Cardiovascular Disease and Section of Vascular Medicine dDivision of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania eDepartment of Medicine, Division of Cardiology, Emory University School of Medicine, Emory Heart and Vascular Center, Atlanta, Georgia fDivision of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama gDepartment of Family and Preventive Medicine, Division of Epidemiology, University of California San Diego, La Jolla, California hCardiology Department, University of Florida, Gainesville, Florida, USA.
authors.forename: Moshrik
authors.initials: M
authors.lastname: Abd Alamir
authors.forename: Susan S
authors.initials: SS
authors.lastname: Ellenberg
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Swerdloff
authors.forename: Nanette K
authors.initials: NK
authors.lastname: Wenger
authors.forename: Emile R
authors.initials: ER
authors.lastname: Mohler
authors.forename: Cora E
authors.initials: CE
authors.lastname: Lewis
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Barrett-Conner
authors.forename: Rine
authors.initials: R
authors.lastname: Nakanishi
authors.forename: Sirous
authors.initials: S
authors.lastname: Darabian
authors.forename: Anas
authors.initials: A
authors.lastname: Alani
authors.forename: Suguru
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Negin
authors.initials: N
authors.lastname: Nezarat
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Snyder
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Budoff
mesh_terms: D000368:Aged; D000728:Androgens; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000000981:diagnostic imaging* / Q000188:drug therapy; D018450:Disease Progression; D004311:Double-Blind Method; D020249:Hormone Replacement Therapy; D006801:Humans; D007006:Hypogonadism / Q000150:complications / Q000188:drug therapy; D008297:Male; D013739:Testosterone / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed
chemical_list: D000728:Androgens; D013739:Testosterone