UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of closed loop stimulation pacing in patients with heart failure
Acronym	closed loop simulation pacing-heart failure
Scientific Title	Efficacy of closed loop stimulation pacing in patients with heart failure
Scientific Title:Acronym	closed loop simulation pacing-heart failure
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of closed loop stimulation for rate adaption in patients with advanced heart failure with cardiac resynchronization therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The differences in NT-proBNP 2. The differences in Minnesota Living With Heart Failure Questionnaire
Key secondary outcomes	The differences in the following parameters during 6 months of closed loop stimulation 1.6-minute walking distance 2.variation in heart rate 3.New York Heart Association classification 4.cardiothoracic ratio 5.parameters in echocardiography 6.rehospitalization rate for acute exacerbation of heart failure, time to rehospitalization, all cause death, all cause rehospitalizatoin 7.kidney function including serum creatinine, eGFR, BUN 8.incidence of atrial fibrillation and its burden 9.percentage of atrial and ventricular pacing

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Activate closed loop stimulation
Interventions/Control_2	Deactivate closed loop stimulation
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	Diagnosed with heart failure according to the ESC 2016 guidelines for the diagnosis and treatment of acute and chronic heart failure CRT-p or CRT-D is needed according to the JCS guidelines for the diagnosis and treatment of acute and chronic heart failure; patients who meet all the following criteria: Receiving optimal medical therapy, NYHA III/IV, sinus rhythm, LVEF(Left ventricular ejection fraction) less than 35%, Left bundle branch block (LBBB) with QRS interval greter than 130 msec Patients who has already implanted with CTT-P/CRT-D and also CLS is inactivated: patients who meet all the following criteria: NYHA II/III/IV, LBBB was documented at device was implated, medication was not changed last 3 months prior to enrollment Age 20 years or more Mental inability to perticipate
Key exclusion criteria	Used at enrollment or planned during study mechanical circulatory suppoft, including intraaortic balloon pumping, percutaneous cardiopulmonary suport, continuous hemodiafiltration, left ventricular assist device Acute coronary syndrome Planned cardiac surgery for heart failure Chronic kidney disease(Creatinene 2.5mg/dl or more) and maintenance dialysis Malignancy Pregnancy or possible pregnancy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ishihara Middle name Last name Shiro
Organization	Nippon Medical School Musashi-Kosugi Hospital
Division name	Department of Cardiology
Zip code	211-8533
Address	1-396 Kosugi-cho, Nakahra-ku, Kawasaki 211-8533, Japan
TEL	044-733-5181
Email	s-ishihara@nms.ac.jp

Public contact
Name of contact person	1st name Ishihara Middle name Last name Shiro
Organization	Nippon Medical School Musashi-Kosugi Hospital
Division name	Department of Cardiology
Zip code	211-8533
Address	1-396 Kosugi-cho, Nakahra-ku, Kawasaki 211-8533, Japan
TEL	044-733-5181
Homepage URL
Email	s-ishihara@nms.ac.jp

Sponsor
Institute	Nippon Medical School Musashi-Kosugi Hospital
Institute
Department

Funding Source
Organization	Nippon Medical School Musashi-Kosugi Hospital
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	Nippon Medical School Musashi-Kosugi Hospital
Address	1-396 Kosugi-cho, Nakahra-ku, Kawasaki 211-8533, Japan
Tel	044-733-5181
Email	s-ishihara@nms.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	2020 Year 01 Month 01 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	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 13 Day
Last modified on	2019 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043007