UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011905 |
|---|---|
| Receipt number | R000013388 |
| Scientific Title | Effect of carnitine supplementation on clinical outcomes in patients with heart failure with preserved ejection fraction |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2022/10/07 14:59:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of carnitine supplementation on clinical outcomes in patients with heart failure with preserved ejection fraction
Acronym
Effect of carnitine supplementation on clinical outcomes in patients with heart failure with preserved ejection fraction
Scientific Title
Effect of carnitine supplementation on clinical outcomes in patients with heart failure with preserved ejection fraction
Scientific Title:Acronym
Effect of carnitine supplementation on clinical outcomes in patients with heart failure with preserved ejection fraction
Region
| Japan |
Condition
Condition
patients with heart failure with preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investage the effect of carnitine supplementation on clinical outcomes in patients with heart failure with preserved ejection fraction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diastolic function assessed by echocardiography
exerecise trelance
Key secondary outcomes
chanes in QOL
Chanes in biomarker (BNP etc)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
supplementation of L-carnitine
Interventions/Control_2
control
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 heart failure with preserved ejection fraction (LVEF = or over 45%)
patients with carnitine deficiency defined as free carnitine level under 36micro mol/L or acyl carnitine/free carnitine ratio= or over 0.4
Key exclusion criteria
patients with acute coronary syndrome, severe valve disease, congenital disease,pulmonary thrombosis, and primary pulmonary hypertention
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamamoto |
Organization
Department of Molecular Medicine and Therapeutics, Tottori University
Division name
Division of Cardiovascular Medicine
Zip code
Address
86 Nishi-cho Yonago
TEL
0859386517
ykazuhiro@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Kinugasa |
Organization
Department of Molecular Medicine and Therapeutics, Tottori University
Division name
Division of Cardiovascular Medicine
Zip code
Address
86 Nishi-cho Yonago
TEL
0859386517
Homepage URL
ykinugasa-circ@umin.ac.jp
Sponsor or person
Institute
Department of Molecular Medicine and Therapeutics, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Other
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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013388
