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 UMIN000006836
Receipt No. 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

* 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 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
Email

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

Sponsor
Institute Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.