UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038380 |
|---|---|
| Receipt number | R000027696 |
| Scientific Title | Yokohama Add-on Inhibitory Efficacy of Dapagliflozin on Left Ventricular Filling Pressure in Patients with Acute Heart Failure with Preserved Ejection Fraction Complicated with type 2 Diabetes Study |
| Date of disclosure of the study information | 2019/10/25 |
| Last modified on | 2020/10/24 10:15:12 |
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Basic information
Public title
Yokohama Add-on Inhibitory Efficacy of Dapagliflozin on Left Ventricular Filling Pressure in Patients with Acute Heart Failure with Preserved Ejection Fraction Complicated with type 2 Diabetes Study
Acronym
D-HFPEF
Scientific Title
Yokohama Add-on Inhibitory Efficacy of Dapagliflozin on Left Ventricular Filling Pressure in Patients with Acute Heart Failure with Preserved Ejection Fraction Complicated with type 2 Diabetes Study
Scientific Title:Acronym
D-HFPEF
Region
| Japan |
Condition
Condition
Acute heart filure with preserved ejection fraction complicated with type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We explore the efficacy and safety of SGLT2 ihibitors for the patients with acute decompensated heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diastolic parameters of echocardiography after 12 weeks ; including left ventricular filling pressure
Key secondary outcomes
BNP, Cr, eGFR, Urinalysis, Endopat, PWV, events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin for 12 weeks
Interventions/Control_2
Alogliptin for 12 weeks
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ADHF with HFpEF complicated with type 2 DM. EF>=40% and stable hemodynamically.
(1)>/=20years old.
(2)type 2 Dm; HbA1c6.5-11.0% (similar to EXAMINE trial)
(3)LVEF>/=40%
(4)agreement with papers
(5)stable state
Key exclusion criteria
(1)type1 DM
(2)pregnancy
(3)CKD stage4, 5
(4)CPK>3 folds of normal range
(5)hepatic injury
(6)NYHA4, oxygenation, intravenous treatment
(7)diabetic ketoacidosis
(8)serious infection
(9)systemic anesthesia, post surgery
(10)sensitive for dapaglifrozin or allogiptin
(11)SGLT2 inhibitor or Dpp4 inhinitor, but they are applicable if in case HbA1c control is not good
(12)incapable controllable DM
(13)pregnancy
(14)if clinician thinks they are not applicable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Iwahashi |
Organization
Yokohama city university medical center
Division name
Division of cardiology
Zip code
232-0024
Address
4-57 Urafune-cho Minami-ku Yokohama
TEL
045-261-5656
niwahash@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Ninomiya |
Organization
Yokohama city university medical center
Division name
Division of cardiology
Zip code
232-0024
Address
4-57 Urafune-cho Minami-ku Yokohama
TEL
045-261-5656
Homepage URL
ninomayu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university medical center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama City University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9 Fukuura Kanazawa-ku Yokohama
Tel
045-370-7627
rinri@yokohama-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 25 | 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
| 2016 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 10 | Month | 24 | Day |
Last modified on
| 2020 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027696
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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