Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)
Information source: Chinese PLA General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Atherosclerosis
Intervention: Olmesartan medoxomil tablets (Drug); Antihypertensive medication (per doctor suggestion) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Chinese PLA General Hospital Official(s) and/or principal investigator(s): Chen Yundai, Principal Investigator, Affiliation: Chinese PLA General Hospital
Overall contact: Zhou Ying, Phone: 86-15810836908, Email: zhouying0129@126.com
Summary
The purpose of this study is to determine whether olmesartan medoxomil is effective in the
treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume
reduction in patients with coronary atherosclerosis detected by coronary CT
angiography(CCTA).
Clinical Details
Official title: Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis Progression and Epicardial Adipose Tissue(EAT) Volume Reduction in Patients With Coronary Atherosclerosis Detected by Coronary CT Angiography(CCTA)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Coronary atherosclerosis progression detected by CCTAEpicardial Adipose Tissue(EAT) volume detected by CCTA
Secondary outcome: The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changesSerum levels of blood lipids Serum levels of blood glucose Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9 Individual circulating surrogate markers of endothelial function including NO and ET-1 Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin.
Detailed description:
Epicardial adipose tissue(EAT) is directly deposited around the pericardium and coronary
artery. By means of paracrine action, it can generate various kinds of cytokines,
inflammatory factor and free fatty acids, that can affect the state of coronary endothelial
function, inflammation and oxidative stress, which finally aggravate the progression of
coronary atherosclerosis. In recent years, clinical studies have shown that EAT is a newly
discovered independent risk factor of coronary atherosclerosis. Studies confirm that
olmesartan medoxomil can improve endothelial function, resisting thrombosis, improve tissue
reconstruction, resisting oxidative stress so as to achieve atherosclerosis resistant.
Latest researches show that olmesartan medoxomil can better inhibit rat epididymal adipose
cell hypertrophy and inflammatory reaction. Coronary CT angiography(CCTA) has emerged as a
noninvasive imaging method for analysis coronary atherosclerosis. The purpose of this study
is to determine whether olmesartan medoxomil is effective in the treatment of coronary
atherosclerosis progression and EAT volume reduction in patients with coronary
atherosclerosis detected by CCTA.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- coronary artery stenosis between 30% and 70% determined by CCTA in essential
hypertension patients
- resting diastolic blood pressure (DBP) between 90 and 110 mmHg
- type A and B for coronary artery vascular lesions
Exclusion Criteria:
- secondary hypertension
- coronary artery stenosis less than 30% or greater than 70% determined by CCTA
- contraindications to treatment with olmesartan medoxomil (allergy, glaucoma,
digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
- resting systolic blood pressure (SBP) > 200 mmHg or resting diastolic blood pressure
(DBP) > 110 mmHg
- Severe calcification, distortion or type C for coronary artery vascular lesions
- pregnancy
- unwillingness or inability to provide informed consent
Locations and Contacts
Zhou Ying, Phone: 86-15810836908, Email: zhouying0129@126.com
Chinese PLA General Hospital, Beijing 100853, China; Recruiting Chen Yundai, Phone: 86-10-55499246, Email: cyundai301@126.com
Additional Information
Related publications: Alexopoulos N, McLean DS, Janik M, Arepalli CD, Stillman AE, Raggi P. Epicardial adipose tissue and coronary artery plaque characteristics. Atherosclerosis. 2010 May;210(1):150-4. doi: 10.1016/j.atherosclerosis.2009.11.020. Epub 2009 Nov 20. Cherian S, Lopaschuk GD, Carvalho E. Cellular cross-talk between epicardial adipose tissue and myocardium in relation to the pathogenesis of cardiovascular disease. Am J Physiol Endocrinol Metab. 2012 Oct 15;303(8):E937-49. doi: 10.1152/ajpendo.00061.2012. Epub 2012 Aug 14. Review. Ferrario C. Effect of angiotensin receptor blockade on endothelial function: focus on olmesartan medoxomil. Vasc Health Risk Manag. 2009;5(1):301-14. Epub 2009 Apr 8. Review. Maeda A, Tamura K, Wakui H, Ohsawa M, Azushima K, Uneda K, Kanaoka T, Kobayashi R, Ohki K, Matsuda M, Tsurumi-Ikeya Y, Yamashita A, Tokita Y, Umemura S. Effects of the Angiotensin receptor blocker olmesartan on adipocyte hypertrophy and function in mice with metabolic disorders. Biomed Res Int. 2014;2014:946492. doi: 10.1155/2014/946492. Epub 2014 Jun 2.
Starting date: December 2014
Last updated: February 6, 2015
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