UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052143 |
|---|---|
| Receipt number | R000059511 |
| Scientific Title | A Prospective Observational Study on Quantification of Nocturnal Respiratory Stability in Heart Failure Patients Using a Non-contact Sensor for Prediction of Heart Failure Outcome and Validity as an Indicator of Heart Failure Severity |
| Date of disclosure of the study information | 2023/09/08 |
| Last modified on | 2024/12/26 11:54:42 |
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Basic information
Public title
An Observational Study on Prediction of Prognosis in Heart Failure Patients by Measuring Respiratory Stability at Night Using a Non-contact Sensor
Acronym
An Observational Study on Prediction of Prognosis in Heart Failure Patients by Measuring Respiratory Stability at Night Using a Non-contact Sensor
Scientific Title
A Prospective Observational Study on Quantification of Nocturnal Respiratory Stability in Heart Failure Patients Using a Non-contact Sensor for Prediction of Heart Failure Outcome and Validity as an Indicator of Heart Failure Severity
Scientific Title:Acronym
A Prospective Observational Study on Quantification of Nocturnal Respiratory Stability in Heart Failure Patients Using a Non-contact Sensor for Prediction of Heart Failure Outcome and Validity as an Indicator of Heart Failure Severity
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to assess whether numerical values obtained non-invasively using piezoelectric sensors to quantify nocturnal respiratory instability in patients hospitalized due to non-compensated heart failure can predict the length of hospital stay, the risk of heart failure readmission, and mortality.
Additionally, we intend to establish appropriate data summarization techniques and cutoff values to ensure the validity of these predictions. This research aims to provide valuable insights into improving the prognosis and risk assessment of non-compensated heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Cardiovascular-related deaths within 1 year of discharge
Key secondary outcomes
Time to all-cause readmission within 1 year of discharge
Time to cardiovascular-related readmission within 1 year of discharge
Number of days in hospital
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
Men and women over 20 years of age hospitalized with heart failure disease
Key exclusion criteria
Patients with significant body movements during the night due to cognitive dysfunction, etc.
Patients on ASV, NPPV, or other forms of ventilatory support
Acute coronary syndrome, chronic obstructive pulmonary disease, pneumonia or other infectious diseases, central nervous system disorders, chronic renal failure with hemodialysis, symptomatic malignancy in the 3 months prior to registration
Other conditions for which the principal investigator deems the subject unsuitable.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tetsuroh |
| Middle name | |
| Last name | Tamaru |
Organization
Shinshu University Graduate School
Division name
Graduate School of Medicine, Science and Technology, Department of Medical Sciences, Health Science Division
Zip code
390-0802
Address
3-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-3376
20ms114h@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuroh |
| Middle name | |
| Last name | Tamaru |
Organization
Shinshu University Graduate School
Division name
Graduate School of Medicine, Science and Technology, Department of Medical Sciences, Health Science
Zip code
390-0802
Address
3-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-3376
Homepage URL
20ms114h@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Tetsuroh Tamaru
Funding Source
Organization
None
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
Shinshu university
Address
3-1 Asahi, Matsumoto City, Nagano Prefecture
Tel
0263-37-3376
mdrinri@shinshu-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
| 2023 | Year | 09 | Month | 08 | 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 | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Method of recruitment of subjects: All adult patients aged 20 years or older who were admitted to the Department of Cardiology, Nagano Central Hospital, with heart failure disease between October 1, 2022 and March 31, 2024, and who met the selection criteria.
Demographic information: gender, age, height, weight, and BMI
History: atrial fibrillation, other arrhythmia, hypertension, coronary artery disease, valvular heart disease, cardiomyopathy, diabetes, chronic kidney disease
Blood and biochemical tests: sodium, hemoglobin, creatinine, estimated glomerular filtration rate, urea nitrogen, cerebral sodium peptide
Echocardiography:
Chest x-ray
Systolic blood pressure, diastolic blood pressure, pulse rate, SpO2, weight
IV drug information: catecholamine, hump, nitroglycerin, and furosemide use
Oxygen therapy information: flow rate, use or non-use
Physical examination: daily shortness of breath at rest, shortness of breath on exertion, leg edema, peripheral coldness
Exercise tolerance: NYHA classification, activity range:
Respiratory instability at night, mean respiratory rate, and mean pulse rate by piezoelectric sensor:
Body motion sensor: Piezola (Z-work) is used to obtain information on respiratory instability, respiratory rate, and pulse rate from 23:00 to 5:00. Respiratory Rate Variability (R2V), which quantifies respiratory instability, is calculated.
Death during hospitalization, presence or absence of hospitalized central failure exacerbation, all-cause mortality in the year after discharge, cardiac disease-related mortality, readmission due to unplanned cardiac disease, time to readmission, and length of hospital stay.
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059511
