UMIN-CTR Clinical Trial

Basic information
Public title	Investigating the Usefulness of Closed loop stimulation for Patients with Cardiac Resynchronization Therapy
Acronym	IPHRS
Scientific Title	Investigating the Usefulness of Physiological Heart Rate Response Sensors for Patients with Cardiac Resynchronization Therapy
Scientific Title:Acronym	ICLST
Region	Japan

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

Objectives
Narrative objectives1	aim: we evaluate the usefulness of closed loop stimulation in CRT patients with chronotropic incompetence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VE/VCO2 slope Cardiopulmonary test is performed on CRT patients with chronotropic incompetence. We compare VE/VCO2 slope in tree difference state (rate response off, CLS on, conventional therapy on)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	rate response off
Interventions/Control_2	conventional rate resposnse
Interventions/Control_3	closed loop stimulation on
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	CRT patients with chronotropic incompetence
Key exclusion criteria	patients with atrial fibrillation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name akira Middle name Last name kasagawa
Organization	St Marianna university
Division name	cardiology
Zip code	216-8511
Address	1-16-2 sugao miyamae-ku kawasaki city kanagawa prefecture
TEL	+81449778111
Email	a2kasagawa@marianna-u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Kasagawa
Organization	St Marianna University
Division name	cardiology
Zip code	216
Address	1-16-2 sugao miyamae-ku kawasaki city kanagawa prefecture
TEL	+81449778111
Homepage URL
Email	a2kasagawa@marianna-u.ac.jp

Sponsor
Institute	St Marianna University
Institute
Department

Funding Source
Organization	St Marianna University
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	St Mariana University
Address	1-16-2 sugao miyamae-ku kawasaki city kanagawa prefecture
Tel	0449778111
Email	a2kasagawa@marianna-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	2022 Year 10 Month 17 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 11 Month 01 Day
Last follow-up date	2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 10 Month 05 Day
Last modified on	2022 Year 10 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055965