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

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 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


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

Value
https://center6.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