UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the Combination of varsartan with HCTZ on circadian BP rhythm
Title of the study (Brief title)	Varsartan & HCTZ
Region	Japan

Condition
Condition	Chronic Kidney Disease (CKD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether or not the additional medication of diuretics to ARB can restore non-dipper circadian BP rhythm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Decrease in the night/day ratio ofmean arterial pressure (MAP)
Key secondary outcomes	office BP, night/day ratios of natriuresis and albuminuria, urinary angiotensinogen excretion rate, plasma catecholamines

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	additional medication of HCTZ (12.5mg/d) to valsartan (80mg/d, once in the morning) for 2 months
Interventions/Control_2
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	1. received medical care at Nagoya City University Hospital; age of 20 or more y 2. CKD criteria based on K/DOQI 3. previous treatment with valsartan (80mg/d) for 2 months or more, office BP >130/80 on at least one occasion 4. documented informed concent
Key exclusion criteria	1. previous treatment with ARB, other than valsartan, or diuretics 2 months before enrollment 2. contraindication to valsartan or HCTZ (history of allergic reaction to them, bilateral renal artery stenosis) 3. presence or possibility of pregnancy 4. HbA1c 9.0 or more % 5. GOT >100, or GPT >85 6. endocrine hypertension 7. accelerated o r malignant hypertension (progressive renal dysfunction with diastolic BP of >120-130 mmHg 8. serious conditions with congestive heart failure, coronary diseases, arrhythmia or systemic diseases 9. nephrotic syndrome (serum albumin <2.5 g/dl) 10. patients under hemodialysis therapy 11. any reason for ineligibility suggested by the attending doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Michio Fukuda
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Cardio-Renal Medicine and Hypertension
Address	1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL	81-52-853-8221
Email	m-fukuda@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Michio Fukuda
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Cardio-Renal Medicine and Hypertension
Address	1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL	81-52-853-8221
Homepage URL
Email	m-fukuda@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	名古屋市立大学病院 Nagoya City University Hospital (愛知県)

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 02 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2015 Year 09 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol	http://www.med.nagoya-cu.ac.jp/cr.dir/
Publication of results	Published
URL releasing results
Results	Of the 25 eligible patients, one had excess BP reduction during add-on HCTZ therapy and another was judged as excessive urine collection, and they were excluded from the study. Lower Na balance was produced by add-on HCTZ to ARB treatment without an increase of intrarenal renin-angiotensin system activity, leading to restoration of nocturnal hypertension. J Renin Angiotensin Aldosterone Syst. 2016 Jun 9;17(2):1470320316652032
Other related information

Management information
Registered date	2011 Year 05 Month 15 Day
Last modified on	2016 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006618