UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012209
Receipt No. 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

* 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 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
Email 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
Email ybando@med.nagoya-u.ac.jp

Sponsor
Institute Cardiology, Nagoya University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014194

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.