UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038879 |
|---|---|
| Receipt number | 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 16:22:12 |
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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
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
s-ishihara@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Musashi-Kosugi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043007
