UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054882 |
|---|---|
| Receipt number | R000062707 |
| Scientific Title | Retrospective observational study on the efficacy and safety of SGLT2 inhibitors in heart failure patients |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2024/07/04 20:51:22 |
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Basic information
Public title
Retrospective observational study on the efficacy and safety of SGLT2 inhibitors in heart failure patients
Acronym
Retrospective observational study on the efficacy and safety of SGLT2 inhibitors in heart failure patients
Scientific Title
Retrospective observational study on the efficacy and safety of SGLT2 inhibitors in heart failure patients
Scientific Title:Acronym
Retrospective observational study on the efficacy and safety of SGLT2 inhibitors in heart failure patients
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, there has been a remarkable development in drugs for heart failure, including conventional beta-blockers (drugs that slow the pulse to give the heart a rest), the renin-angiotensin-aldosterone system inhibitors (drugs that prevent fluid retention and lower blood pressure). In addition to these drugs, SGLT2 inhibitors have been attracting attention for their ability to prevent hospitalization for heart failure, suppress cardiovascular events, and inhibit the progression of chronic kidney disease. The four drugs, which include SGLT2 inhibitors in addition to conventional anti-heart failure drugs, are called the "Fantastic four," and are expected to make a significant contribution to improving the prognosis of heart failure patients. On the other hand, SGLT2 inhibitors, which are originally used for diabetes treatment, have a hypoglycemic effect by inhibiting the reabsorption of sugar released into the urine by the kidneys. This may lead to sarcopenia (loss of muscle mass and thinning) in patients with low dietary intake and in the elderly. Therefore, this is a clinical trial to verify the efficacy and safety of SGLT2 inhibitors as a treatment for heart failure in the elderly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause mortality and heart failure rehospitalization one year after discharge from initial heart failure hospitalization
Key secondary outcomes
Hospitalization for urinary tract infection, ischemic stroke, or dehydration one year after initial heart failure hospitalization and discharge
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients over 80 years old
Key exclusion criteria
Patients discharged from initial heart failure hospitalization with death
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
TEL
093-511-2000
kanesannsann@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Nakano |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
TEL
093-511-2000
Homepage URL
nakano.kenji55@gmail.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
none
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
Kokura Memorial Hospital Clinical Research Review Committee
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
Tel
093-511-2000
rinsyorinsyo@kokurakinen01.onmicrosoft.com
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 | 07 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.kokurakinen.or.jp/bumon/rinsyoukenkyu/chiken/
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
1559
Results
Of the 1559 cases, 1326 were included in the non-SGLT2i group and 233 in the SGLT2i group. The follow-up rate was 95.6%.
Results date posted
| 2024 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 1559 cases, 1326 were included in the non-SGLT2i group and 233 in the SGLT2i group. The follow-up rate was 95.6%.
Participant flow
Of the 1559 cases, 1326 were included in the non-SGLT2i group and 233 in the SGLT2i group. The follow-up rate was 95.6%.
Adverse events
There was no increase in the SGLT2i group with respect to safety endpoints.
Outcome measures
All-cause mortality and heart failure rehospitalization were reduced in the SGLT2i group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062707
