UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008128 |
|---|---|
| Receipt number | R000009486 |
| Scientific Title | Mie Cardio-Renal and Vascular Echocardiographic Investigation in Patients Receiving Hemodialytic Therapy: MIE CARE-HD |
| Date of disclosure of the study information | 2012/06/09 |
| Last modified on | 2020/06/29 14:59:37 |
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Basic information
Public title
Mie Cardio-Renal and Vascular Echocardiographic Investigation in Patients Receiving Hemodialytic Therapy: MIE CARE-HD
Acronym
MIE CARE-HD
Scientific Title
Mie Cardio-Renal and Vascular Echocardiographic Investigation in Patients Receiving Hemodialytic Therapy: MIE CARE-HD
Scientific Title:Acronym
MIE CARE-HD
Region
| Japan |
Condition
Condition
chronic hemodialysis patients
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We thought to evaluate the prevalence, severity, and annual progression rate of cardiovascular disease, especially focusing on valvular heart disease by using echocardiography, and to elucidate their impacts on patient outcome in patients on chronic hemodialysis.
Basic objectives2
Others
Basic objectives -Others
epidemiology and pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite outcome of hospitalization for heart failure or death from heart failure.
Key secondary outcomes
Death from any cause
Hospitalization for heart failure
Death from heart failure
Hospitalization for any cardiovascular event other than heart failure
Death from any cardiovascular event other than heart failure
Annual change in aortic valve area
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic renal failure who has been continuing maintenance dialysis for one year or more
Key exclusion criteria
Lack of capacity to give informed consent
Patient refusal
Patient regarded that remainder of his or her life is within one year due to diseases other than kidney or heart disease
Patients who would be difficult to follow up
Patients whose attending physician decided not eligible for the study entry
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8507
Address
2-174 Edobashi Tsu-city Mie, Japan
TEL
059-232-1111
dohik@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Molecular and Laboratory Medicine
Zip code
514-8507
Address
2-174 Edobashi Tsu-city Mie, Japan
TEL
059-232-1111
Homepage URL
dohik@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant from the Suzuken Memorial Foundation
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
Mie University IRB
Address
2-174 Edobashi Tsu-city Mie, Japan
Tel
059-232-1111
s-kenkyu@mo.medic.mie-u.ac.jp
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
桑名東医療センター（三重県）、村瀬病院（三重県）、武内病院（三重県）、済生会松阪総合病院（三重県）、伊勢赤十字病院（三重県）、尾鷲総合病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29093429
Number of participants that the trial has enrolled
315
Results
Patients with ESRD on chronic HD have a high prevalence of cardiac structural and functional abnormalities including calcified aortic sclerosis. High age and PTH were associated with aortic valve narrowing in these patients.
Results date posted
| 2020 | Year | 06 | Month | 28 | Day |
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline clinical characteristics of patients
Medications
Physical examination
Dialysis prescription
Electrocardiography
Chest x-ray
Blood test
Echocardiography
Vascular ultrasound including carotid and peripheral arteries
Annual follow-up for detection of clinical events
Management information
Registered date
| 2012 | Year | 06 | Month | 08 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009486
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
