UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015685 |
|---|---|
| Receipt number | R000018232 |
| Scientific Title | Investigation of the impact of DPP-4 inhibition on serum brain natriuretic peptide level of diabetic patients with congestive heart failure. |
| Date of disclosure of the study information | 2014/11/13 |
| Last modified on | 2014/11/13 22:53:16 |
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Basic information
Public title
Investigation of the impact of DPP-4 inhibition on serum brain natriuretic peptide level of diabetic patients with congestive heart failure.
Acronym
DPP-4 inhibitor and serum BNP level of diabetic patients with congestive heart failure.
Scientific Title
Investigation of the impact of DPP-4 inhibition on serum brain natriuretic peptide level of diabetic patients with congestive heart failure.
Scientific Title:Acronym
DPP-4 inhibitor and serum BNP level of diabetic patients with congestive heart failure.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus, congestive heart failure
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of DPP-4 inhibitor on the serum BNP level and cardiac function of diabetic patients with congestive heart failure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum BNP level and cardiac function evaluated by echocardiography with and without DPP-4 inhibitor use.
Key secondary outcomes
Blood glucose, serum insulin, HbA1c, body weight, serum SDF-1 alpha, serum active GLP-1, serum active GIP with and without DPP-4 inhibitor use.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anaglitpin, saxagliptin
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetes with congestive heart failure under treatment with DPP-4 inhibitor.
2. High serum BNP (200-2000pg/ml) measured after October 2013.
Key exclusion criteria
1. HbA1c over 9.0%
2. Patients changed treatment within 3 months before inclusion
3. Judged as ineligible by clinical investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Isogawa |
Organization
Mitsui Memorial Hospital
Division name
Division of diabetes
Zip code
Address
1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL
+81-3-3862-9111
isogawa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Isogawa |
Organization
Mitsui Memorial Hospital
Division name
Division of diabetes
Zip code
Address
1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL
+81-3-3862-9111
Homepage URL
isogawa-tky@umin.ac.jp
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Research fund of mitsukoshi health and welfare foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
三井記念病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 13 | Day |
Last modified on
| 2014 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018232
