UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005796 |
|---|---|
| Receipt number | R000006851 |
| Scientific Title | Aliskiren Evaluation on Left Ventricular Diastolic Dysfunction |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2013/10/08 10:44:48 |
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Basic information
Public title
Aliskiren Evaluation on Left Ventricular Diastolic Dysfunction
Acronym
ALEDY
Scientific Title
Aliskiren Evaluation on Left Ventricular Diastolic Dysfunction
Scientific Title:Acronym
ALEDY
Region
| Japan |
Condition
Condition
Heart failure with preserved ejection fraction and hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Aliskiren on diastolic function and collagen metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LV diastolic function,
biomarker of myocardial fibrillation and systemic inflammation,
coronary flow velocity reserve
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aliskiren group and Standard therapy group
Interventions/Control_2
test period 24weeks
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
age; 20-80 years old
Bp>140/90mmHg
LVEF>45%
Diastlic dysfunction by Doppler echocardiography
Key exclusion criteria
secondary HT,
Diabetes Mellitus,
significant systolic dysfunction,
serum creatinine>2mg/dl,
significant liver dysfunction,
acute phase of myocardial infarction or cerebrovascular disease atrial fibrillation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Watanabe |
Organization
Sakakibara Heart Institite
Division name
Department of Cardiology
Zip code
Address
3-16-1 Asahi-cho Hutyu-shi Tokyo
TEL
042-314-3111
hwatana@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Shinoki |
Organization
Clinical Trials Support Office
Division name
Clinical Trials Support Office
Zip code
Address
3-16-1 Asahi-cho Hutyu-shi Tokyo
TEL
042-314-3111
Homepage URL
tiken@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institite
Institute
Department
Personal name
Funding Source
Organization
Japan Research Promotion Society for Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
| 2011 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2011 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 18 | Day |
Last modified on
| 2013 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006851
