UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037942 |
|---|---|
| Receipt number | R000043248 |
| Scientific Title | An Exploratory Study of Telemonitoring for Patients with Chronic Heart Failure using Non-Invasive Recording Devices |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2021/07/09 16:53:16 |
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Basic information
Public title
An Exploratory Study of Telemonitoring for Patients with Chronic Heart Failure using Non-Invasive Recording Devices
Acronym
An Exploratory Study of Telemonitoring for Patients with Chronic Heart Failure using Non-Invasive Recording Devices
Scientific Title
An Exploratory Study of Telemonitoring for Patients with Chronic Heart Failure using Non-Invasive Recording Devices
Scientific Title:Acronym
An Exploratory Study of Telemonitoring for Patients with Chronic Heart Failure using Non-Invasive Recording Devices
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes of non-invasive vital parameters against symptoms of worsening heart failure in patients with chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between symptoms of worsening heart failure and changes of non-invasive vital parameters such as ECG, heart sounds, body water content, blood pressure, and body weight.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Acoustic Cardiography, Body Composition Monitor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Outpatients with chronic heart failure; 2)Patients with a history of hospitalization due to heart failure symptoms; 3)Patients with high worsening risk for heart failure selected by investigators; 4)Patients who accept the non-invasive recordings twice a week at their home
Key exclusion criteria
1)Patients with severe arrhythmia, angina, aortic valve stenosis; 2)Patients with severe complications: malignant tumor, severe respiratory diseases, severe cerebrovascular diseases, severe liver and renal dysfunction
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Kuwahata |
Organization
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Division name
Cardiovascular Medicine
Zip code
8912124
Address
1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
TEL
0994-32-5211
sokuwahata@ybb.ne.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Kuwahata |
Organization
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Division name
Cardiovascular Medicine
Zip code
8912124
Address
1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
TEL
0994-32-5211
Homepage URL
sokuwahata@ybb.ne.jp
Sponsor or person
Institute
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Corporation
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
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Address
1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
Tel
0994-32-5211
tarumizuhp@tarumizumh.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
| 2019 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 24 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 02 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 05 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043248
