UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Respiratory monitoring and clinical outcome in patients with implantable cardioverter-defibrillator
Title of the study (Brief title)	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	Eiichi Watanabe
Organization	Fujita Health University School of Medicine
Division name	Department of Cardiology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL	0562-9-2312
Email	enwatan@fujita-hu.ac.jp

Public contact
Name of contact person	Eiichi Watanabe
Organization	Fujita Health University School of Medicine
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 19 Day
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

Related information
URL releasing protocol	https://resolve2013.jimdo.com/
Publication of results	Unpublished
URL releasing results
Results
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