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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000319
Receipt No. R000000412
Scientific Title The Effect of Losartan and Amlodipine on Left Ventricular Diastolic Function in Patients With Mild-to-Moderate Hypertension
Date of disclosure of the study information 2006/02/01
Last modified on 2011/02/01

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Basic information
Public title The Effect of Losartan and Amlodipine on Left Ventricular Diastolic Function in Patients With Mild-to-Moderate Hypertension
Acronym J-ELAN
Scientific Title The Effect of Losartan and Amlodipine on Left Ventricular Diastolic Function in Patients With Mild-to-Moderate Hypertension
Scientific Title:Acronym J-ELAN
Region
Japan

Condition
Condition Hypertensive heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess the effects of losartan and amlodipine on LV diastolic function in hypertensive patients with LV diastolic dysfunction in absence of systolic dysfunction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes LV diastolic function
Key secondary outcomes carotid artery atherosclerosis
BNP
PIIIP
CITP
high sensitivity C-reactive protein

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 treatment with angiotensin II type 1 receptor blocker
Interventions/Control_2 treatment with calcium channel blocker
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 •Mild to moderate hypertension (systolic blood pressure with 140 mmHg or over and with 200 mmHg or less, diastolic blood pressure with 90 mmHg or over and with 110 mmHg or less,
•Presence of LV hypertrophy (a ratio of LV mass to body surface area (LV mass index) with 120 g/m2 or over in men and with 105 g/m2 or over in women, or LV wall thickness > 11 mm.
•LV diastolic dysfunction (a ratio of peak early to late diastolic filling velocities (E/A) < 1.0 or > 1.5, an E-wave deceleration time <160 msec or >280 msec, isovolumic relaxation time <60 msec or > 105 msec)
•LV ejection fraction with 50% or over
Key exclusion criteria •History of a life-threatening adverse event induced by ARB or CCB
•Pregnant woman
•Serious liver dysfunction (aspartate aminotransferase or alanine aminotransferase more than 10 times of normal upper limit)
•Serum creatinine > 1.8 mg/dl, known bilateral renal artery stenosis, single kidney, renal sclerosis
•Secondary hypertension, malignant hypertension, hypertensive encephalopathy
•Cardiovascular or cerebrovascular accidents within the last 6 months
•Patients with angina pectoris who need CCB or beta-blocker
•Significant aortic stenosis (peak transaortic valve pressure gradient > 20 mmHg)
•Important aortic or mitral regurgitation in the investigators opinion
•Patients with other diseases which affect the serum levels of carboxy-terminal telopeptide of collagen type I (CITP) and carboxy-terminal of procollagen type III (PIIIP)
•Prescription of ACEI or ARB within 5 months
•Prescription of beta-blocker or CCB within 4 weeks
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatsugu Hori
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita 565-0871, Japan
TEL 06-6879-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Yamamoto
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita 565-0871, Japan
TEL 06-6879-5111
Homepage URL http://poppy.ac/j-elan/
Email kazuhiro@medone.med.osaka-u.ac.jp

Sponsor
Institute J-ELAN study group
Institute
Department

Funding Source
Organization Osaka Heart Club
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2006 Year 02 Month 01 Day

Related information
URL releasing protocol http://poppy.ac/j-elan/
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Under the similar reduction of blood pressure, losartan is likely effective in protecting the progression of atherosclerosis of the carotid artery compared to amlodipine.  Losartan may improve LV diastolic function, and amlodipine may attenuate LV hypertrophy; however this study cannot make consecutive remarks about the superiority of either treatment regimen in the effects on cardiac function and geometry. 
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 12 Month 27 Day
Date of IRB
Anticipated trial start date
2005 Year 03 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 08 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information Yamamoto K, Ozaki H, Takayasu K, Akehi N, Fukui S, Sakai A, Kodama M, Shimonagata T, Kobayashi H, Ota M, Horiguchi Y, Ebisuno S, Katsube Y, Yamazaki T, Ohtsu H, Hori M. The Effect of losartan and amlodipine on left ventricular diastolic function and atherosclerosis in Japanese patients with mild-to-moderate hypertension -J-ELAN study- Hypertens Res (in press)

Management information
Registered date
2006 Year 02 Month 01 Day
Last modified on
2011 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000412

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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