UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012209 |
|---|---|
| Receipt number | R000014194 |
| Scientific Title | Assessment of medical treatment of diabetes on comorbid diastolic let-ventricular dysfunction observed by cardiac MRI in diabetic patients |
| Date of disclosure of the study information | 2013/11/04 |
| Last modified on | 2014/06/25 14:23:19 |
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Basic information
Public title
Assessment of medical treatment of diabetes on comorbid diastolic let-ventricular dysfunction observed by cardiac MRI in diabetic patients
Acronym
DMDHF-CMR
Scientific Title
Assessment of medical treatment of diabetes on comorbid diastolic let-ventricular dysfunction observed by cardiac MRI in diabetic patients
Scientific Title:Acronym
DMDHF-CMR
Region
| Japan |
Condition
Condition
Heart failure with diastolic dysfunction and comorbid diabetes.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the impact of therapeutic intervention for diabetes on diastolic left-ventricular dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Changes in LV early filling by use of CMR.
Key secondary outcomes
MACE
incidence of hospitalization by heart failure Changes in E/e'
Changes in NT-proBNP
Changes in endothelial function
Changes in circulating DPP4 activity and biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of DPP4 inhibitor sitagliptin for 1 year
Interventions/Control_2
Oral administration of anti-diabetic drugs except for DPP4 inhibitor sitagliptin for 1 year
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
70y/o or older
male and female
T2DM
diastolic dysfunction positive
NYHAI-II
No previous Hx of hospitalization due to heart failure
No hypertension (SBP less than 150 and DBP less than 90)
Approved informed consent
Key exclusion criteria
MACE within 3 months
LVEF<50%
Comorbid atrial fibrillation
MR at more than moderate grade
Patients taking DPP4i or GLP-1 analog
ESRD or HD patient
T1DM
Malignancy within 5 years
Uncontrolled arrhythmia
Encontralled hypertension
Expecting hospitalization within 6 months
Insulin treatment
Indication of cardiac surgery
liver injury
Autoimmune disease
Pulmonary fibrosis
Unstable AP or coronary spastic angina
ASO (>Fontaine grade II)
Contraindication for MRI
Drug allergy to sitagliptin and any antidiabetic drug.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko K. Bando |
Organization
Nagoya University
Division name
Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2147
ybando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko K. Bando |
Organization
Nagoya University
Division name
Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2147
Homepage URL
ybando@med.nagoya-u.ac.jp
Sponsor or person
Institute
Cardiology, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Mitsubishi-Nagoya hospital
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
名古屋大学医学部附属病院
三菱名古屋病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 04 | Day |
Last modified on
| 2014 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014194
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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