UMIN ID: UMIN000000944
Registered date:01/11/2008
Effect of olmesartan on diurnal blood pressure profile, vascular function, oxidative stress, and renal renin-angiotensin system in hypertensives with chronic kidney disease
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension with chronic kidney disease |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Olmesartan group: To achieve blood pressure control below 130/80 mmHg, start with once-daily dosing of olmesartan 5-10 mg, and increase up to 10-40 mg if effect of olmesartan on the clinical parameters is insufficient. If necessary, a combination therapy by several anti-hypertensives will be performed to achive casual blood pressure control below 130/80 mmHg. Control group: To achieve blood pressure control below 130/80 mmHg, start with anti-hypertensives including ACE inhibitor but other than ARBs, and increase dosage of respective anti-hypertensives if effect of first-line anti-hypertensives on the clinical parameters is insufficient. If necessary, a combination therapy by several anti-hypertensives will be performed to achive casual blood pressure control below 130/80 mmHg. |
Outcome(s)
| Primary Outcome | 1) Abdominal circumference 2) Casual blood pressure, home blood pressure. 3) Diurnal blood pressure profile by ambulatory blood pressure monitoring. 4) Glucose metabolism: FPG, IRI, HbA1c. 5) Renal function: Urinary protein excretion, BUN, urinary creatinine excretion, urinary albumin excretion, eGFR, urinary type IV collagen excretion. 6) Lipid metabolism: total cholesterol, LDL cholesterol, tryglyceride, HDL-choresterol. 7) Cardiac function: BNP. 8) Vascular function: ABI/PWV, FMD. 9) Inflamation and oxidative stress marker: hs-CRP, adiponectin, plasma apelin, urinary 8-OHdG. 10) Markers of intra-renal renin-angiotensin system: plasma and urinary angiotensinogen. 11) Genotype of renin-angiotensin system: angiotensinogen, renin, AT1 receptor, ATRAP, Nedd4L. 12) Examination of renal biopsy specimen (glomerular sclerosis, fibrosis, and expression of ATRAP and AT1 receptor mRNA and protein). |
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| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
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| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Pregnant women, or women suspected of being pregnant. 2) Hyperkalemia. 3) Bilateral renal artery stenosis. 4) History of hypersensitivity to the administered olmesartan. |
Related Information
| Primary Sponsor | Department of Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuaki Uchino |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan |
| Telephone | 045-787-2635 |
| mai_mew963@hotmail.com | |
| Affiliation | Yokohama City University Hospital Department of Cardiorenal Medicine |
| scientific contact | |
| Name | Kouichi Tamura |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan |
| Telephone | 045-787-2635 |
| tamukou@med.yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University, Graduate School of Medicine Department of Medical Science and Cardiorenal Medicine |