Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)
- Conditions
- Coronary Atherosclerosis
- Interventions
- Drug: Antihypertensive medication (per doctor suggestion)
- Registration Number
- NCT02360956
- Lead Sponsor
- Chinese PLA General Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olmesartan medoxomil Olmesartan medoxomil tablets Drug: Olmesartan medoxomil tablets(Daiichi Sankyo Inc, Japan). The initial dose is 20mg once daily. If blood pressure requiring further reduction after two weeks, olmesartan medoxomil may be increased to 40mg once daily. Antihypertensive medication Antihypertensive medication (per doctor suggestion) Drug:Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except angiotensin-Converting Enzyme Inhibitors inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs). The drug dose must be individualized.
- Primary Outcome Measures
Name Time Method Epicardial Adipose Tissue(EAT) volume detected by CCTA 12 month Coronary atherosclerosis progression detected by CCTA 12 month Coronary atherosclerosis progression is defined as ≥10% diameter reduction or progression of a pre-existing coronary stenosis; or ≥0.2mm reduction or progression of the minimal luminal area (MLD) in the lesion
- Secondary Outcome Measures
Name Time Method The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes 12 month Serum levels of blood lipids 12 month Blood lipids include total cholesterol,triglyceride,high density lipoprotein(HDL) and low density lipoprotein(LDL).
Serum levels of blood glucose 12 month Blood glucose is defined as fasting blood glucose(FBG).
Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9 12 month CRP: C reactive protein; IL: Interleukin; MCP: Monocyte chemotactic protein,composite of chemoattractant markers; TNF-α: tumor necrosis factor; MMP: Matrix metalloproteinase.
Individual circulating surrogate markers of endothelial function including NO and ET-1 12 month ET: Endothelin
Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin. 12 month
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, China