UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048843 |
|---|---|
| Receipt number | R000055655 |
| Scientific Title | Predictors of heart failure with preserved ejection fraction in patients with diabetes mellitus: exercise stress echocardiographic study |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/03/05 09:36:08 |
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Basic information
Public title
Predictors of heart failure with preserved ejection fraction in patients with diabetes mellitus: exercise stress echocardiographic study
Acronym
Koto-DM Heart study
Scientific Title
Predictors of heart failure with preserved ejection fraction in patients with diabetes mellitus: exercise stress echocardiographic study
Scientific Title:Acronym
Koto-DM Heart study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the predictors of heart failure with preserved ejection fraction in patients with diabetes mellitus (DM) during exercise stress echocardiography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of heart failure
Key secondary outcomes
Cardiovascular death.
The occurrence of atrial fibrillation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Patients are performed exercise stress echocardiography. Echocardiographic parameters during exercise are analyzed.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with preserved left ventricular ejection fraction who are treated for diabetes mellitus more than three months and kept in steady states.
Key exclusion criteria
Patients with history of ischemic heart disease within six months
Patients with more than moderate degree of valvular disease
Patients who are treated for chronic obstructive pulmonary disease
Patients with Chronic kidney disease
Patients with liver disease
Patients with active malignancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Yamano |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular Medicine
Zip code
602-8566
Address
Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
+81-75-251-5511
m-kuro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Yamano |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular Medicine
Zip code
602-8566
Address
Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
+81-75-251-5511
Homepage URL
m-kuro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Institutional Review Board
Address
Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
Tel
+81-75-251-5111
rinri@koto.kpu-m.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
| 2022 | Year | 10 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2029 | 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
| 2022 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055655
