UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060357 |
|---|---|
| Receipt number | R000068834 |
| Scientific Title | Clinical Utility of Respiratory Stability Time for Early identification of Worsening Heart Failure: A Multicenter Regional Collaboration Study |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/14 10:43:59 |
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Basic information
Public title
Clinical Utility of Respiratory Stability Time for Early Identification of Worsening Heart Failure: A Multicenter Regional Collaboration Study
Acronym
CORE-RST study
Scientific Title
Clinical Utility of Respiratory Stability Time for Early identification of Worsening Heart Failure: A Multicenter Regional Collaboration Study
Scientific Title:Acronym
CORE-RST study
Region
| Japan |
Condition
Condition
Heart Failure Patients
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate whether RST serves as a useful indicator for early detection of heart failure exacerbation in the disease management of heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of RST reduction during the period from 60 to 14 days prior to the onset date for cases of worsening heart failure where clinically significant objective findings deteriorate alongside worsening heart failure symptoms and signs.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with heart failure according to the Heart Failure Management Guidelines (JCS/JHFS 2025)
2) Patients with a serum NT-proBNP level of 300 pg/mL or higher at the time of consent acquisition
3) Patients for whom written consent for study participation has been obtained from the patient or a legal representative
4) Patients aged 20 years or older
Key exclusion criteria
1) Patients whose bed or futon may be used for sleeping by individuals other than the study subject or by pets
2) Patients who, due to lifestyle factors, cannot undergo regular respiratory monitoring for at least 2 hours per night on 3 or more days per week
3) Patients without spontaneous breathing
4) Patients receiving treatment for chronic obstructive pulmonary disease (COPD)
5) Patients receiving assisted ventilation therapy such as Adaptive Servo-Ventilation (ASV) or Continuous Positive Airway Pressure (CPAP) therapy during sleep
6) Pregnant patients
7) Patients whose primary diagnosis is Obstructive Sleep Apnea Syndrome (OSAS)
8) Patients receiving guidance management using information from an implantable cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
9) Patients with a history of cerebral hemorrhage or cerebral infarction, regardless of presence of sequelae
10) Patients undergoing dialysis therapy for renal failure or scheduled to start during the observation period
11) Patients currently participating in interventional studies (including clinical trials)
12) Patients for whom follow-up during the observation period is not feasible
13) Besides the above, patients deemed inappropriate by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sato |
Organization
Kawaguchi Cardiovascular and Respiratory Hospital
Division name
Cardiology
Zip code
333-0842
Address
1-1-51, Maekawa, Kawaguchi, Saitama
TEL
048-264-5533
nms-ns@nms.ac.jp
Public contact
Name of contact person
| 1st name | Research Administration Office |
| Middle name | |
| Last name | Contact person |
Organization
Public Health Research Foundation
Division name
CSP-LD
Zip code
169-0051
Address
1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo
TEL
03-5287-2639
Homepage URL
CORE-RST_LD19@csp.or.jp
Sponsor or person
Institute
Kawaguchi Cardiovascular and Respiratory Hospital
Institute
Department
Personal name
Funding Source
Organization
HeartLab.Inc
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
Kawaguchi Cardiovascular and Respiratory Hospital Ethics Committee
Address
1-1-51, Maekawa, Kawaguchi, Saitama
Tel
048-264-5533
---
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
かわぐち心臓呼吸器病院（埼玉県）
はなまるクリニック（神奈川県）
済生会熊本病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design: Multicenter observational study (non-interventional, non-invasive, single-arm study)
The values of data from the RST calculation program during the study will be blinded to researchers and study subjects.
Research Summary: Respiratory Stability Time (RST) is a physiological indicator that quantifies respiratory stability. RST is automatically calculated from body motion signals extracted by a motion sensor placed on bedding. It has been suggested that RST can detect worsening heart failure in outpatients before the onset of heart failure symptoms.
This study investigates whether RST can detect worsening heart failure earlier than conventional heart failure assessment indicators in patients receiving disease management through outpatient treatment.
Management information
Registered date
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068834
