UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Title of the study (Brief title)	The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of a combination drug of an angiotenshin II receptor blockers (ARB) and a low-dose diuretic vs combination therapy with an ARB and an angiotensin converting enzyme (ACE) inhibitor in hypertensive patients with left ventricular diastolic dysfunction. In addition to the effect on left ventricular diastolic dysfunction, the study aims to evaluate the efficacy on myocardial hypertrophy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 48 weeks of treatment
Key secondary outcomes	- Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 24 weeks of treatment - Change and % change in blood pressure after 4, 24 and 48 weeks of treatment - Change and % change in BNP, cathecholamine 3 fractionation, hs-CRP, plasma renin activity and aldosterone levels after 24 and 48 weeks of treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Losartan/HCTZ group
Interventions/Control_2	Losartan (50mg) and Enalapril (5mg) combination group
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria: 1) Outpatients (men and women) aged 20 to 80 years at the time of the first visit 2) Patients with hypertension, who have been previously treated with monotherapy of a standard-dose of ARB for more than 1 month, however, whose blood pressure has not been adequately controlled (systolic blood pressure>=140mmHg and/or diastolic blood pressure>=90mmHg) 3) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria	Exclusion criteria: 1) Patients with secondary hypertension 2) Patients with uncontrolled hypertension (DBP>=120mmHg) 3) Patients with uncontrolled diabetes (HbA1c>=8.0%) 4) Patients with cardiac insufficiency (over NYHA grade III) 5) Patients with renal failure (serum creatinine>=2.0mg/dl) 6) Patients with liver dysfunction (GOT or GPT>=100IU/L) 7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (UA>=8.0mg/dl) 8) Patients with hyperkalemia (K>=5.5mEq/L) 9) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 10) Patients with a history of hypersensitivity to ingredients of the study drugs 11) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Yoji Neishi
Organization	Kawasaki Medical School
Division name	Division of Cardiology
Address	577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL	086-462-1111
Email	neishi@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Yoji Neishi
Organization	Kawasaki Medical School
Division name	Division of Cardiology
Address	577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email	neishi@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
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	川崎医科大学　（岡山県） Kawasaki Medical School (Okayama)

Other administrative information
Date of disclosure of the study information	2009 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 27 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2011 Year 11 Month 01 Day
Date of closure to data entry	2012 Year 12 Month 31 Day
Date trial data considered complete	2013 Year 03 Month 31 Day
Date analysis concluded	2013 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 09 Month 13 Day
Last modified on	2018 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003047