UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058393 |
|---|---|
| Receipt number | R000066718 |
| Scientific Title | Association between heart failure pharmacotherapy and nutritional status in patients with heart failure |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/08 12:27:20 |
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Basic information
Public title
Association between heart failure pharmacotherapy and nutritional status
Acronym
Association between heart failure pharmacotherapy and nutritional status
Scientific Title
Association between heart failure pharmacotherapy and nutritional status in patients with heart failure
Scientific Title:Acronym
Association between heart failure pharmacotherapy and nutritional status
Region
| Japan |
Condition
Condition
Heart Failure (HF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the first worsening of nutritional status after HF hospitalization (HHF), stratified by the number of HF drugs prescribed during HHF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to the first worsening of nutritional status (Controlling Nutritional Status score [CONUT score]/Geriatric Nutritional Risk Index [GNRI], Prognostic Nutritional Index [PNI]) from baseline.
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) Patients aged >= 18 years who are diagnosed with HF during hospitalization within the Study Period
(2) Patients discharged on or after Index Date.
(3) Patients with CONUT, GNRI, or PNI data during the Baseline Period and after Baseline Period.
(4) Patients who have medical records in the Medical Data Vision Co., Ltd. (MDV) database for one year or more before the Index Date.
Key exclusion criteria
(1) Patients who have ICD-10 codes identifying HF before Index Date.
(2) Patients who underwent cardiac pacemaker, implantable cardioverter-defibrillator implantation, cardiac resynchronization therapy, catheter ablation, coronary artery bypass graft surgery, percutaneous coronary intervention, surgical or percutaneous intervention for heart valve disease in Look Back Period.
(3) Patients who were hospitalized for acute myocardial infarction in Look Back Period.
Target sample size
300000
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Nishiya |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Dept. 1 Clinical Development Medical Affairs Cardio Renal Metabolism, Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo
TEL
070-2793-7296
yoichi.nishiya@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Asano |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Dept. 1 Clinical Development Medical Affairs Cardio Renal Metabolism, Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo
TEL
070-3979-1845
Homepage URL
daiki.asano@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
Sumitomosibadaimon Bld.12F,2-5-5, Shibadaimon, Minato-ku, Tokyo,Japan
Tel
03-5733-5010
rihds@jmdc.co.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 | 07 | Month | 07 | 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
| 2025 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study using an existing database, the MDV database. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require informed consent from the patients.
Management information
Registered date
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066718
