Clinical trial NCT02360956: Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Atherosclerosis
Keywords: Olmesartan medoxomil
Epicardial adipose tissue
Multidetector Computed Tomography
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Coronary atherosclerosis progression detected by CCTA
timeFrame: 12 month
measure: Epicardial Adipose Tissue(EAT) volume detected by CCTA
timeFrame: 12 month
Secondary outcomes:
measure: The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes
timeFrame: 12 month
measure: Serum levels of blood lipids
timeFrame: 12 month
measure: Serum levels of blood glucose
timeFrame: 12 month
measure: Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9
timeFrame: 12 month
measure: Individual circulating surrogate markers of endothelial function including NO and ET-1
timeFrame: 12 month
measure: Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin.
timeFrame: 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Chen Yundai
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Ferrario C. Effect of angiotensin receptor blockade on endothelial function: focus on olmesartan medoxomil. Vasc Health Risk Manag. 2009;5(1):301-14. doi: 10.2147/vhrm.s3141. Epub 2009 Apr 8.
citation: 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.
citation: Zhou Y, Tian F, Wang J, Yang JJ, Zhang T, Jing J, Chen YD. Efficacy study of olmesartan medoxomil on coronary atherosclerosis progression and epicardial adipose tissue volume reduction in patients with coronary atherosclerosis detected by coronary computed tomography angiography: study protocol for a randomized controlled trial. Trials. 2016 Jan 6;17:10. doi: 10.1186/s13063-015-1097-z.