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

• Type of Material: Article
• Authors: Moshrik Abd Alamir, University of California Los Angeles; Susan S. Ellenberg, University of Pennsylvania; Ronald S. Swerdloff, University of California Los Angeles; Nanette Wenger, Emory University; Emile R Mohler, University of Pennsylvania; Cora E. Lewis, University of Alabama Birmingham; Elizabeth Barrett-Conner, University of California San Diego; Rine Nakanishi, University of California Los Angeles; Sirous Darabian, University of California Los Angeles; Anas Alani, University of Florida; Suguru Matsumoto, University of California Los Angeles; Negin Nezarat, University of California Los Angeles; Peter J. Snyder, University of Pennsylvania; Matthew J. Budoff, University of California Los Angeles
• Language: English
• Date: 2016-03-01
• Publisher: Lippincott, Williams & Wilkins
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2016 Wolters Kluwer Health, Inc. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1097/MCA.0000000000000321
• Title of Journal or Parent Work: Coronary Artery Disease
• ISSN: 0954-6928
• Volume: 27
• Issue: 2
• Start Page: 95
• End Page: 103
• Grant/Funding Information: 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: INTRAVASCULAR ULTRASOUND; coronary computed tomographic angiography; Life Sciences & Biomedicine; THERAPY; ARTERY-DISEASE; MYOCARDIAL-INFARCTION; cardiovascular disease; Science & Technology; ENDOGENOUS SEX-HORMONES; CT ANGIOGRAPHY; Cardiovascular System & Cardiology; OLDER MEN; Cardiac & Cardiovascular Systems; PLAQUE; testosterone; randomized controlled trial; HEART-RATE-VARIABILITY; DIAGNOSTIC-ACCURACY; coronary artery plaque progression
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, General

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.