UMIN ID: UMIN000000665
Registered date:01/11/2008
EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Hypertension, end-stage renal disease on peritoneal dialysis |
Date of first enrollment | 2004/09/01 |
Target sample size | 60 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | ARB group: Start with once-daily dosing of valsartan 20-40 mg or candesartan 2-4 mg, and increase up to 80-160 mg for valsartan and 8-12 mg for candesartan, respectively, if effects of valsartan or candesartan on the clinical parameters are insufficient. Target blood pressure is less than 140/90 mmHg. Control therapy group: Treated with anti-hypertensives principally by other than ARBs or ACE inhibitors.Target blood pressure is less than 140/90 mmHg. |
Outcome(s)
Primary Outcome | 1) body weight, residual urinary volume. 2) casual blood pressure. 3) ambulatory blood pressure profile, blood pressure variability. 4) cardiac ultrasonography (IVSd, LVDd, LVPWd, LVDs, FS, EF(modified simpson method), E/A, DcT, etc). 5) ABI/baPWV. 6) blood parameters. CBC: Hb, Ht, fibrinogen Biochemistry: TP, Alb, BUN, s-Cr, UA, Na, K, Cl, Ca, P, GOT, GPT, Alp, T-bil, T-cho, HDL, LDL, TG, beta2-microglobulin. Endocrine: cathecholamine, PRA, PAC, ANP, BNP. Serological: CRP. 7) ECG. 8) Chest Xp. 9) Weekly erythropietin dosage. |
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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 | Malignancy, overt heart failure, acute myocardial infarction, collagen disease, acute renal failure, hyperkalemia, Pregnant women, or women suspected of being pregnant, history of hypersensitivity to valsartan or candesartan, severe hepatic disease |
Related Information
Primary Sponsor | Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine |
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Secondary Sponsor | Fujisawa Municipal Hospital |
Source(s) of Monetary Support | Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine |
Secondary ID(s) |
Contact
public contact | |
Name | Kazuaki UCHINO |
Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN Japan |
Telephone | 045-787-2634 |
uchinok@med.yokohama-cu.ac.jp | |
Affiliation | Yokohama City University School of Medicine Department of Medical Science |
scientific contact | |
Name | Kouichi TAMURA |
Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN Japan |
Telephone | 045-787-2635 |
tamukou@med.yokohama-cu.ac.jp | |
Affiliation | Yokohama City University School of Medicine Department of Cardiorenal Medicine |