UMIN-CTR Clinical Trial

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
Email	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
Email	sokuwahata@ybb.ne.jp

Sponsor
Institute	Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043248