Unique ID issued by UMIN | UMIN000000665 |
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Receipt number | R000000794 |
Scientific Title | EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. |
Date of disclosure of the study information | 2008/11/01 |
Last modified on | 2015/09/19 09:50:08 |
EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
Japan |
Hypertension, end-stage renal disease on peritoneal dialysis
Medicine in general | Cardiology | Endocrinology and Metabolism |
Nephrology |
Others
NO
Angiotensin II type 1 receptor blockers (ARB) have shown various protective effects to the cardiovascular system. However, using ARB is associated with several adverse effects including worsening of hyperkalemia and anemia, especially in end-stage renal disease (ESRD) patients. Cardiovascular diseases are the main cause of death in ESRD patients, and cardiovascular risk in patients on continuous ambulatory peritoneal dialysis (CAPD) may differ from that in those on hemodialysis (HD). Maintaining extracellular fluid and salt balance is a major challenge in dialysis patients, and especially so in CAPD patients with minimal or no residual diuresis. The degree of left ventricular dysfunction is suggested to be more severe in long-term CAPD patients than in HD patients with more pronounced volume expansion, hypertension, and hypoalbuminemia. This study was performed to examine whether ARB is useful for the treatment of hypertension in CAPD patients.
Efficacy
Confirmatory
Pragmatic
Phase IV
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
ESRD patients with blood pressure >= 140/90 mmHg and >= 20 years old under CAPD treatment for more than six months were enrolled.
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
60
1st name | |
Middle name | |
Last name | Kouichi TAMURA |
Yokohama City University School of Medicine
Department of Cardiorenal Medicine
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
045-787-2635
tamukou@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Kazuaki UCHINO |
Yokohama City University School of Medicine
Department of Medical Science
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
045-787-2634
uchinok@med.yokohama-cu.ac.jp
Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Self funding
Fujisawa Municipal Hospital
NO
2008 | Year | 11 | Month | 01 | Day |
Published
Completed
2004 | Year | 08 | Month | 01 | Day |
2004 | Year | 09 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 09 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2007 | Year | 03 | Month | 31 | Day |
2015 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000794
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