UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053988 |
|---|---|
| Receipt number | R000061631 |
| Scientific Title | Efficacy of SGLT2 inhibitors in heart failure patients with preserved left ventricular function |
| Date of disclosure of the study information | 2024/03/27 |
| Last modified on | 2024/09/26 10:28:56 |
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Basic information
Public title
Efficacy of SGLT2 inhibitors in heart failure patients with preserved left ventricular function
Acronym
Efficacy of SGLT2 inhibitors in heart failure patients
Scientific Title
Efficacy of SGLT2 inhibitors in heart failure patients with preserved left ventricular function
Scientific Title:Acronym
Efficacy of SGLT2 inhibitors in heart failure patients with preserved left ventricular function
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the multi-organ effects of SGLT2 inhibitors in heart failure patients with preserved left ventricular function and establish their potential as anti-ageing agents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in hepcidin and exercise tolerance measured six months after induction of SGLT2 inhibitors
Key secondary outcomes
NT-proBNP, cardiac MRI (fibrosis, atrial and ventricular capacitance, and functional parameters)
Changes in hematopoietic, renal, and skeletal muscle parameters
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Heart failure patients with preserved left ventricular function in whom SGLT2 inhibitors were initiated in chronic heart failure, chronic kidney disease or diabetes mellitus
Key exclusion criteria
Persons who have difficulty in obtaining consent in person
Persons who have refused to participate in the study.
Other persons deemed unsuitable as research subjects by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-Ku, Tokyo
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-Ku, Tokyo
TEL
03-3972-8111
Homepage URL
okumura.yasuo@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine, Division of Cardiology, Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Oyaguchi-Kamicho, Itabashi-Ku, Tokyo
Tel
0339728111
med.rinsyokenkyu@nihon-u.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
| 2024 | Year | 03 | Month | 27 | 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
35
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of the examination are being reviewed approximately six months after the introduction of SGLT2.
Management information
Registered date
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061631
