UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011498 |
|---|---|
| Receipt number | R000013455 |
| Scientific Title | Impact of L-Carnitine supplementation for hemodialysis patients with heart failure. |
| Date of disclosure of the study information | 2013/08/16 |
| Last modified on | 2013/08/16 07:16:01 |
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Basic information
Public title
Impact of L-Carnitine supplementation for hemodialysis patients with heart failure.
Acronym
Impact of L-Carnitine supplementation for hemodialysis patients with heart failure.
Scientific Title
Impact of L-Carnitine supplementation for hemodialysis patients with heart failure.
Scientific Title:Acronym
Impact of L-Carnitine supplementation for hemodialysis patients with heart failure.
Region
| Japan |
Condition
Condition
hemodialysis patients, heart failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the impact of L-Carnitine supplementation on chronic hemodialysis patients for heart failure with preserved ejection fraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left atrial volume indexed to body surface area, early-to-atrial left ventricular filling ratio, The ratio of transmitral Doppler early filling velocity to tissue Doppler early diastolic
mitral annular velocity.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
duration: 6 months.
amount:L-Cartin FF injection 1000mg or 900 mg of L-carnitine.
times: 3 times per week after HD sessions or orally intake.
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
1, More than dialysis history 3 year
2, sufficient understanding top after being given to sufficient explanation in the participation in this research, and a patient -- the patient by whom the document consent by the free will of the person himself/herself was got
3, The patient who had the view of the contractile dysfunction of the left ventricle, or heart failure with preserved ejection fraction in the cardiac echo check for the past less than 12 months
Key exclusion criteria
1, A patient with the past of allergy to L-carnitine
2, A pregnant woman or the woman that may have become pregnant
3, The patient who took the supplement of carnitine less than 1 month before registration
4, The patient who judged that a principal investigator was unsuitable as a subject
5, A patient with a high possibility that spring suit medicine will be uncontinuable for six months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akiba |
Organization
Tokyo Women's Medical University
Division name
Blood purification
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Blood purification
Zip code
Address
TEL
Homepage URL
kamei-wak@umin.net
Sponsor or person
Institute
Department of Blood purification, Kidney Center, Tokyo Women's Medical University
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
| 2013 | Year | 08 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 16 | Day |
Last modified on
| 2013 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013455
| 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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