UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000739 |
|---|---|
| Receipt number | R000000888 |
| Scientific Title | Long-term evolution and changing associations of left ventricular hypertrophy after starting hemodialysis |
| Date of disclosure of the study information | 2007/06/20 |
| Last modified on | 2007/06/13 13:43:56 |
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Basic information
Public title
Long-term evolution and changing associations of left ventricular hypertrophy after starting hemodialysis
Acronym
Evolution and associations of LVH
Scientific Title
Long-term evolution and changing associations of left ventricular hypertrophy after starting hemodialysis
Scientific Title:Acronym
Evolution and associations of LVH
Region
| Japan |
Condition
Condition
hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined the evolution of LVH after starting dialysis and the determinants of changes in LV mass.
Basic objectives2
Others
Basic objectives -Others
To examine the effect of cardiac function on all cause and cardiovascular mortality.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
changes in LV mass index (LVMI)
Key secondary outcomes
all cause and cardiovascular mortality.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients had been receiving regular hemodialysis for at least 6 months at one of our three hospitals following the inception of dialysis therapy at Tsuchiura Kyodo General Hospital
Key exclusion criteria
Patients who had a technically unsatisfactory echocardiogram
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Takeda |
Organization
Tsuchiura Kyodo General Hospital
Division name
Kidney Center
Zip code
Address
11-7, Manabeshinmachi, Tsuchiura-shi, Ibaraki-ken, 300-0032, Japan
TEL
029-823-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Takeda |
Organization
Midorino Clinic
Division name
Director
Zip code
Address
2526-1, Nishimura, Kutsukake, Bando-shi, Ibaraki-ken, 306-0515, Japan
TEL
0297-30-3311
Homepage URL
atakeda@midorino.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2007 | 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
At baseline, the mean LV mass index (LVMI) was 145.8 g/ m2 and 73 (68%) patients had LVH. During the mean follow-up period of 34.5 months, the mean LVMI decreased by 4.3 g/ m2. At last follow-up, the mean LVMI was 141.5 g/ m2 and 68 (64%) patients had LVH. For changes in LVMI, a significant correlation was found in changes in systolic blood pressure, LVMI at baseline, ischemic heart disease, and changes in serum albumin concentration. The relationship between changes in LVMI and systolic blood pressure was close during the 1st and 2nd intervals, but became weak gradually during the 3rd and 4th intervals.
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
| 1998 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1998 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2005 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 02 | Month | 01 | Day |
Other
Other related information
Many patients had LVH at starting hemodialysis and continued to have LVH thereafter. The most important determinant of LV mass changes was systolic blood pressure control, but the effect decreased gradually with time. These results suggest that active antihypertensive treatment should be started early, even if a few years have elapsed after the initiation of dialysis, to regress LVH and prevent cardiovascular diseases.
Management information
Registered date
| 2007 | Year | 06 | Month | 13 | Day |
Last modified on
| 2007 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000888
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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