UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000319 |
|---|---|
| Receipt number | 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 09:56:55 |
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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
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/
kazuhiro@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
J-ELAN study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000412
