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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038879
Receipt No. R000043007
Scientific Title Efficacy of closed loop stimulation pacing in patients with heart failure
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/13

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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

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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