UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028335
Receipt number 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 2020/07/25 17:51:55

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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 Kiyoshi
Middle name
Last name Iida

Organization

Nihon University Hospital

Division name

Cardiology

Zip code

101-8309

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 Nobuko
Middle name
Last name Fujimoto

Organization

Nihon University Hospital

Division name

Cardiology

Zip code

101-8309

Address

1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan

TEL

03-3293-1711

Homepage URL


Email

fujimoto.nobuko@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University Hospital

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

Nihon University Hospital

Address

1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan

Tel

03-3293-1711

Email

iida.kiyoshi@nihon-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

2017 Year 07 Month 23 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032422

Publication of results

Published


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032422

Number of participants that the trial has enrolled

40

Results

See attached documents

Results date posted

2020 Year 07 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

See attached documents

Participant flow

See attached documents

Adverse events

None

Outcome measures

See attached documents

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 07 Day

Date of IRB

2017 Year 06 Month 08 Day

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

2020 Year 07 Month 25 Day

Date analysis concluded

2020 Year 07 Month 25 Day


Other

Other related information



Management information

Registered date

2017 Year 07 Month 23 Day

Last modified on

2020 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032422


Research Plan
Registered date File name
2020/07/25 オーディコアAM-RT臨床研究_研究プロトコル.docx

Research case data specifications
Registered date File name
2020/07/25 オーディコアAM-RT臨床研究_症例報告書.docx

Research case data
Registered date File name
2020/07/25 ACARE-HF研究総括報告書Amend_20200318clean.docx