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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028335
Receipt No. R000032422
Scientific Title An Exploratory Study of the AUDICOR Parameters in Patients with Heart Failure during CPX Test and Exercise Therapy
Date of disclosure of the study information 2017/07/23
Last modified on 2019/01/24

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Basic information
Public title An Exploratory Study of the AUDICOR Parameters in Patients with Heart Failure during CPX Test and Exercise Therapy
Acronym ACARE-HF (A pilot study)
Scientific Title An Exploratory Study of the AUDICOR Parameters in Patients with Heart Failure during CPX Test and Exercise Therapy
Scientific Title:Acronym ACARE-HF (A pilot study)
Region
Japan

Condition
Condition Chronic Heart Failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine possibility of estimating AT workload based on AUDICOR parameters
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate correlation between AT workload and its estimate derived from AUDICOR parameters
Key secondary outcomes Investigate how AUDICOR parameter curve versus heart rate shift during each exercise therapy moves depending on exercise therapy progress

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 Electrocardiogram, Acoustic Cardiography
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with Heart Failure
2) Cardiac patients who are selected for cardiac rehabilitation and are able to perform CPX.
3) Patients who gave written informed consent
Key exclusion criteria Patients with Acute Heart Failure
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Iida
Organization Nihon University Hospital
Division name Cardiology
Zip code
Address 1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan
TEL 03-3293-1711
Email iida.kiyoshi@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuko Fujimoto
Organization Nihon University Hospital
Division name Cardiology
Zip code
Address 1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan
TEL 03-3293-1711
Homepage URL
Email fujimoto.nobuko@nihon-u.ac.jp

Sponsor
Institute Nihon University Hospital
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
Address
Tel
Email

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
2017 Year 07 Month 23 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
2018 Year 09 Month 19 Day
Date of closure to data entry
2019 Year 01 Month 24 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 23 Day
Last modified on
2019 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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