UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006836 |
|---|---|
| Receipt number | R000008089 |
| Scientific Title | Role of Diabetes in heart failure with preserved left ventricular function |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2013/08/02 17:55:37 |
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Basic information
Public title
Role of Diabetes in heart failure
with preserved left ventricular function
Acronym
HFPEF and DM
Scientific Title
Role of Diabetes in heart failure
with preserved left ventricular function
Scientific Title:Acronym
HFPEF and DM
Region
| Japan |
Condition
Condition
HFPEF patients with T2DM
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the impact of therapeutic intervention in diabetes on left ventricular diastolic dysfunction and remodeling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in diastolic left ventricular function assessed by echocardiography (E/e')
Key secondary outcomes
Major cardiovascular event
admission due to deteriarated heart failure
changes in serum NT-proBNP value
changes in biomarkers value
changes in delayed enhancement observed each heart detected by cardiac MRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
Multicentered cohort study (PROBE study in multicenter)
GroupA; sitagliptin (50/100mg/day) treatment
Data accessment each 6 month for 2 years
Interventions/Control_2
Multicentered cohort study (PROBE study in multicenter)
GroupB; therapeutic intervention by remedy except for DPP4 inhibitor.
Data accessment each 6 month for 2 years
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 40 or above
Male and female
Ambulatory patient exhibiting his/her HbA1C value is between 6.0% and 8.9%
Left ventricular ejection fraction assessed by echocardiography is more than 50%
Left ventricular diastolic function parameters assessed by echocardiography
satisfy the conditions as follows;
#1 E/e more than 15
#2 E/e between 8 and 15
and
NT-proBNP; more than 900pg/mL
#3 E/e between 8 and 15
or NT-proBNP more than 900pg/mL
and RAd-Ad more than 30msec.
or LAVI more than 40mL/m2
or LVMImore than 110g/m2 in male and 100g/m2 in female
Key exclusion criteria
Major cardiovascular events within 3 months after registration
Left ventricular ejection fraction is less than 50 percent
Left ventricular diastolic diameter is more than 49mm
Comorbid atrial fibrillation
Diabetic patients who is treated by DPP-4 inhibitors and/or GLP-1analog
Patients with CKD [eGFR less than 30ml] and ESRD
Type 1 diabetes
Malignancy within 5 years at registration
Uncontrolled cormobid arrhythmia
Uncontrolled cormobid hypertension
Hospitalization within 6 month
Diabetic patients who is treated by insulin
Comorbid severe valuvular heart disease
Comorbid severe ischemic heart disease
Liver injury [ALT/AST values exhibit 5 times higher than normal range]
Pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko K Bando |
Organization
Nagoya University Hospital
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2147
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko K Bando |
Organization
Nagoya University Hospital
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2147
Homepage URL
ybando@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 01 | 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
| 2011 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 05 | Day |
Last modified on
| 2013 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008089
