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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026322
Receipt No. R000029882
Scientific Title Respiratory monitoring and clinical outcome in patients with implantable cardioverter-defibrillator
Date of disclosure of the study information 2017/03/06
Last modified on 2017/02/27

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Basic information
Public title Respiratory monitoring and clinical outcome
in patients with implantable cardioverter-defibrillator
Acronym RESOLVE study
Scientific Title Respiratory monitoring and clinical outcome
in patients with implantable cardioverter-defibrillator
Scientific Title:Acronym RESOLVE study
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objectives of this study are to examine how biosignal measurements change with worsening heart failure.
Basic objectives2 Others
Basic objectives -Others The purpose of this study was to collect sensor data about patient events during worsening heart failure and develop algorithms capable of
detecting the onset of worsening heart failure prior to the overt presentation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Acute exacerbation of heart failure
Key secondary outcomes To examine associations betwen changes in the biosignal including respiratory rate, sleep disordered bleething, heart rate, and patient activity and clinical characteristics or clinical outcomes

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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age 18 or above
2. Willing to participate in all testing associated with this clinical investigation at an clinical investigational center
3. Currently implanted with an INCEPTA device
4. Classified as NYHA Class II - IV within the last six months
5. Indication of the ICD CRT-D implantation along with ACC/AHA/HRS 2008 Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities

Key exclusion criteria Inability or refusal to sign the Subject Informed Consent or inability of refusal to comply with the follow-up schedule
Contraindication for ICD or CRT-D
Have received or will receive heart transplant
Receiving mechanical circulatory support
A life expectancy of less than 12 months due to non-cardiac cause
Documented as pacemaker dependent
Pregnant or lactating
Less than 18 years of age
Enrolled in any other clinical study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Watanabe
Organization Fujita Health University School of Medicine
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562-9-2312
Email enwatan@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Watanabe
Organization Fujita Health University School of Medicine
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562-9-2312
Homepage URL
Email enwatan@fujita-hu.ac.jp

Sponsor
Institute Department of Cardiology
Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology
Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization Other
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 03 Month 06 Day

Related information
URL releasing protocol https://resolve2013.jimdo.com/
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
2013 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 19 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Increased number of patients are implanted with implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT - D) as treatment for rehospitalization and sudden death due to heart failure. As a sign of deterioration of heart failure, fluid retention, increase in pulse rate and decrease in heart rate variability are observed. BOSTON Scientific's INCEPTA series ICD has a function to distinguish breathing information such as respiration frequency and sleeping respiratory disturbances. Therefore, by combining breathing information in addition to heart rate variability and body fluid storage status, it is expected that prognosis improvement can be obtained by early detection of signs of heart failure deterioration and treatment intervention. In this study, we are registering BOSTON Scientific's ICD implanted patients from multiple institutions, and we examine the relationship between respiratory condition and heart failure hospitalization and the occurrence of arrhythmia.Approximately 150 patients are targeted for patients implanted (or planned to be implanted) with BOSTON's implantable cardioverter defibrillator.

Management information
Registered date
2017 Year 02 Month 27 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029882

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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