UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063506 |
|---|---|
| Receipt number | R000072673 |
| Scientific Title | Type two diabetes mellitus and heart failure with preserved ejection fraction treated with tirzepatide effects on exercise capacity |
| Date of disclosure of the study information | 2026/11/04 |
| Last modified on | 2026/11/03 17:18:22 |
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Basic information
Public title
Type two diabetes mellitus and heart failure with preserved ejection fraction treated with tirzepatide effects on exercise capacity
Acronym
TOPAZ study
Scientific Title
Type two diabetes mellitus and heart failure with preserved ejection fraction treated with tirzepatide effects on exercise capacity
Scientific Title:Acronym
TOPAZ study
Region
| Japan |
Condition
Condition
Type two diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of tirzepatide, initiated as an approved treatment for type 2 diabetes mellitus, on exercise capacity in patients with type 2 diabetes mellitus and heart failure with preserved ejection fraction (HFpEF), compared with optimized standard diabetes care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in peak VO2 from baseline to Week 24.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Tirzepatide
Interventions/Control_2
control
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
Patients aged 20 years or older with type 2 diabetes mellitus, LVEF >45%, and clinical evidence of HFpEF based on hemodynamic, biomarker, echocardiographic, or hospitalization criteria.
Key exclusion criteria
Patients with severe cardiac or systemic disease, current GLP-1/GIP agonist use, recent cardiovascular hospitalization, CPET contraindications, or other conditions deemed unsuitable.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | SHUNICHI |
| Middle name | |
| Last name | DOI |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
s2doi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | SHUNICHI |
| Middle name | |
| Last name | DOI |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
s2doi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
s2doi@marianna-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
| 2026 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2026 | Year | 11 | Month | 03 | Day |
Last modified on
| 2026 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072673
