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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000739
Receipt No. 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

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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
Email

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
Email atakeda@midorino.com

Sponsor
Institute Tsuchiura Kyodo General Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000888

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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