UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061582 |
|---|---|
| Receipt number | R000070436 |
| Scientific Title | Prospective Observational Study of Masimo Pulse Oximeter Measurements for Congestion Assessment and Outcome Prediction in Patients with Heart Failure |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/13 19:21:39 |
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Basic information
Public title
Prospective Observational Study of Masimo Pulse Oximeter Measurements for Congestion Assessment and Outcome Prediction in Patients with Heart Failure
Acronym
N/A
Scientific Title
Prospective Observational Study of Masimo Pulse Oximeter Measurements for Congestion Assessment and Outcome Prediction in Patients with Heart Failure
Scientific Title:Acronym
N/A
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
he objective of this study is to prospectively evaluate the association between measurements obtained using a noninvasive Masimo pulse oximeter and the degree of congestion in patients with heart failure, and to assess the utility of these measurements for predicting clinical outcomes, including length of hospital stay, in-hospital mortality, and readmission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between Masimo-derived measurements and established markers of congestion, including BNP or NT-proBNP levels, chest radiographic findings, inferior vena cava diameter, and lung ultrasound findings
Association between Masimo-derived measurements and clinical outcomes, including heart failure readmission within 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients aged 18 years or older
Patients hospitalized for or treated in the outpatient setting for heart failure
Key exclusion criteria
Patients in whom adequate measurements using the Masimo pulse oximeter cannot be obtained
Patients deemed inappropriate for study participation by the investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Maeda |
Organization
Konan Medical Center, Public Interest Foundation Kohnankai
Division name
Department of Cardiology
Zip code
658-0064
Address
1-5-16 Kamokogahara, Higashinada-ku, Kobe, Hyogo 658-0064, Japan
TEL
078-851-2161
maeda.takanori.tokushima@gmail.com
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Maeda |
Organization
Konan Medical Center, Public Interest Foundation Kohnankai
Division name
Department of Cardiology
Zip code
658-0064
Address
1-5-16 Kamokogahara, Higashinada-ku, Kobe, Hyogo 658-0064, Japan
TEL
078-851-2161
Homepage URL
maeda.takanori.tokushima@gmail.com
Sponsor or person
Institute
Konan Medical Center
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Institutional Review Board Office, Konan Medical Center
Address
1-5-16 Kamokogahara, Higashinada-ku, Kobe, Hyogo 658-0064, Japan
Tel
078-851-2161
maeda.takanori.tokushima@gmail.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
| 2026 | Year | 06 | Month | 01 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070436
