UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045259
Receipt number R000051696
Scientific Title Efficacy of LAVITA home monitoring system in patients with heart failure
Date of disclosure of the study information 2021/08/25
Last modified on 2024/02/08 09:00:40

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Basic information

Public title

Efficacy of LAVITA home monitoring system in patients with heart failure

Acronym

LAVITA pilot study

Scientific Title

Efficacy of LAVITA home monitoring system in patients with heart failure

Scientific Title:Acronym

LAVITA pilot study

Region

Japan


Condition

Condition

Heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the execution rate of the LAVITA home care self-monitoring system in patients with heart failure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement rates of body weight, blood pressure, pulse rate, SpO2, and activity levels from 9 to 12 weeks.

Key secondary outcomes

Differences of following variables from baseline to 12 weeks (3 months).
1) Bodyweight
2) Vital signs (blood pressure, pulse rate)
3) SpO2
4) activity level (steps)
5) NT-proBNP
6) CTR by CXR
7) LVEF, LVDd/Ds, E/e'
8) Heart failure readmission
9) All-cause death


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

Able to access the LAVITA-web application via their smartphone or PC
Have wi-fi network at their home
Diagnosed with heart failure
Able to input their daily biometric data via the application

Key exclusion criteria

Unable to use a smartphone daily
No wi-fi network
Unable to use the LAVITA-web application

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Soichiro
Middle name
Last name Usui

Organization

Kanazawa University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

9208641

Address

13-1 Takaramachi Kanazawa ishikawa

TEL

076-265-2000

Email

usuiso@staff.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Nomura

Organization

Kanazawa University

Division name

Innovative Clinical Research Center

Zip code

9208641

Address

13-1 Takaramachi Kanazawa ishikawa

TEL

076-265-2049

Homepage URL


Email

anomura@med.kanazawa-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Nihon Koden corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Ethics Committee of Kanazawa University

Address

13-1 Takaramachi Kanazawa ishikawa

Tel

076-265-2110

Email

rinri@adm.kanazawa-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

金沢大学附属病院


Other administrative information

Date of disclosure of the study information

2021 Year 08 Month 25 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

2021 Year 05 Month 26 Day

Date of IRB

2021 Year 05 Month 26 Day

Anticipated trial start date

2021 Year 09 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Registration will be started on September 2021.


Management information

Registered date

2021 Year 08 Month 25 Day

Last modified on

2024 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051696


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name