UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059584 |
|---|---|
| Receipt number | R000068146 |
| Scientific Title | Evaluation of alterations in circulating disease-related factors induced by SGLT2 inhibitor therapy in patients with heart failure |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/29 19:56:57 |
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Basic information
Public title
Evaluation of alterations in circulating disease-related factors induced by SGLT2 inhibitor therapy in patients with heart failure
Acronym
Analysis of changes in blood biomarkers in patients with heart failure treated with SGLT2 inhibitors
Scientific Title
Evaluation of alterations in circulating disease-related factors induced by SGLT2 inhibitor therapy in patients with heart failure
Scientific Title:Acronym
Changes in pathophysiological biomarkers after SGLT2 inhibitor treatment in patients with heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the changes and trajectories of circulating pathophysiology-related biomarkers before and after SGLT2 inhibitor treatment in patients with heart failure.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in circulating pathophysiology-related biomarkers
Key secondary outcomes
Changes in circulating inflammatory cytokines
Association between genotypes involved in the pharmacological effects of SGLT2 inhibitors and therapeutic response
Changes in circulating metabolism-related biomarkers
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 45 years or older
2. Patients with no prior treatment with SGLT2 inhibitors
3. Patients with signs and symptoms of heart failure (HF) as determined by the principal investigator
Key exclusion criteria
1. Patients expected to have a life expectancy of less than 3 years due to non-cardiovascular causes
2. Patients currently in a state of decompensated heart failure
3. Patients with valvular disease considered hemodynamically significant by the principal investigator
4. Patients who are candidates for cardiac surgery or catheter intervention
5. Patients with tachycardia exceeding 110 beats per minute at screening
6. Patients with currently life-threatening arrhythmias
7. Patients in whom the principal investigator strongly suspects another primary cause of symptoms (including, but not limited to, the following):
a. Isolated pulmonary arterial hypertension or right-sided heart failure without left-sided heart failure
b. Anemia (hemoglobin < 10 g/dL)
c. Severe chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring chronic oxygen therapy, nebulizer use, or oral corticosteroid therapy
8. Patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or those undergoing dialysis
9. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than three times the upper limit of normal (ULN)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
+81-53-435-2767
kojisuzu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
+81-53-435-2767
Homepage URL
kojisuzu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School 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
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
Tel
+81-53-435-2680
rinri@hama-med.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
| 2025 | Year | 10 | Month | 30 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Study Design]
Single-center, prospective observational study
[Objective]
To clarify how the initiation of treatment with SGLT2 inhibitors affects the levels of pathophysiology-related blood markers in patients with heart failure.
[Study Population]
1. Men and women aged 45 years or older
2. Patients with no prior treatment with SGLT2 inhibitors
3. Patients with signs and symptoms of heart failure (HF) as determined by the principal investigator
Management information
Registered date
| 2025 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068146
