UMIN-CTR Clinical Trial

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

Heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Cardiology
Fujita Health University School of Medicine

Institute

Department

Personal name

Organization

Department of Cardiology
Fujita Health University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

03

Month

06

Day

URL releasing protocol

https://resolve2013.jimdo.com/

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

02

Month

27

Day

Last modified on

2017

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029882