UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049598 |
|---|---|
| Receipt number | R000056484 |
| Scientific Title | A multicenter observational study to evaluate the association between mineralocorticoid receptor antagonist and urine albumin-creatinine ratio at 6 months in heart failure patients with hypertension |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2025/05/27 12:21:57 |
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Basic information
Public title
A multicenter observational study to evaluate the association between mineralocorticoid receptor antagonist and urine albumin-creatinine ratio at 6 months in heart failure patients with hypertension
Acronym
A multicenter observational study to evaluate the association between mineralocorticoid receptor antagonist and urine albumin-creatinine ratio at 6 months in heart failure patients with hypertension
Scientific Title
A multicenter observational study to evaluate the association between mineralocorticoid receptor antagonist and urine albumin-creatinine ratio at 6 months in heart failure patients with hypertension
Scientific Title:Acronym
A multicenter observational study to evaluate the association between mineralocorticoid receptor antagonist and urine albumin-creatinine ratio at 6 months in heart failure patients with hypertension
Region
| Japan |
Condition
Condition
Hypertension, heart failure, chronic kidney disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between mineralocorticoid receptor antagonist and urine albumin-creatinine ratio at 6 months in heart failure patients with hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine albumin-creatinine ratio at 6 months
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hypertension
2. Heart failure requiring hospitalization
3. UACR>=30mg/gCr
4. K<5.1mEq/L
Key exclusion criteria
1. MRA use at screening
2. eGFR<30
3. Acute coronary syndrome
4. Planned surgery within 6 months
5. Patients who cannot give their consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovascular medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku, Sendai
TEL
022-717-7153
chart@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Cardiovascular medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku, Sendai
TEL
0227177153
Homepage URL
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院、大崎市民病院、仙台オープン病院、仙台医療センター、県南中核病院、気仙沼市立病院、岩手県立中央病院、JA秋田厚生連平鹿総合病院、いわき市医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
eGFR,
urinary salt Excretion
LVEF, LVLS, E/e,TRPG,TAPSE, LVMI, LAVI
Serum renin, aldosteron, BNP
6MWD, KCCQ
Kideny events (reduction of eGFR over40%, end-stage renal failure, and renal death)
CV events (cardiovascular death and heart failure)
Management information
Registered date
| 2022 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056484
