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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000665
Receipt No. 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

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Basic information
Public title EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
Acronym EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
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.
Scientific Title:Acronym EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS ON AMBULATORY BLOOD PRESSURE AND CARDIOVASCULAR FUNCTION IN HYPERTENSIVE PATIENTS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.
Region
Japan

Condition
Condition Hypertension, end-stage renal disease on peritoneal dialysis
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 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.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 Control therapy group: Treated with anti-hypertensives principally by other than ARBs or ACE inhibitors.Target blood pressure is less than 140/90 mmHg.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ESRD patients with blood pressure >= 140/90 mmHg and >= 20 years old under CAPD treatment for more than six months were enrolled.
Key exclusion 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Email tamukou@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuaki UCHINO
Organization Yokohama City University School of Medicine
Division name Department of Medical Science
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2634
Homepage URL
Email uchinok@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Fujisawa Municipal Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 09 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 31 Day
Last modified on
2015 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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