UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007060 |
|---|---|
| Receipt number | R000008196 |
| Scientific Title | Correlation of Heart Failure Tendency and Respiration Count of REPLY |
| Date of disclosure of the study information | 2012/01/13 |
| Last modified on | 2016/03/08 09:04:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Correlation of Heart Failure Tendency and Respiration Count of REPLY
Acronym
REPLY Study
Scientific Title
Correlation of Heart Failure Tendency and Respiration Count of REPLY
Scientific Title:Acronym
REPLY Study
Region
| Japan |
Condition
Condition
Patients with implanted pacemaker device
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a correlation between indices of heart failure tendency and the number of respiration counts with more than 10 seconds interval.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The exsistence of a correlation between indices of heart failure tendency (BNP, CTR, NYHA class and the number of hospitalization due to heart failure) and the number of respiration counts with more than 10 seconds interval.
Key secondary outcomes
-The existence of a correlation between value of BNP and NYHA class
-Progression of NYHA class during the study
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients implanted or to be implanted device for the study (Reply DR) according to the Guidelines for Non-Pharmacological Therapy of Cardiac Arrhythmias (JCS 2006)
-Patients who meet either of the following criteria
1) LVEF: 45% or less
2) NYHA class: II or more
-Patients received sufficient explanation of the study and signed on informed consent
Key exclusion criteria
-Patients who do not consent
-Patients not able to come to regular pacemaker follow-up due to any reason such as geographical restrictions
-Contraindicated or any possibilities to meet warnings in IFU
-Age of less than 20 years
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Yagi |
Organization
Sendai City Hospital
Division name
Division of Cardiology
Zip code
Address
3-1 Shimizu-koji, Wakabayashi-ku, Sendai City, Miyagi, 984-8501, Japan,
TEL
03-6711-5263
m-nomura@jll.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjiro Hara |
Organization
Japan Lifeline Co., Ltd.
Division name
Cardiac Rhythm Management Division
Zip code
Address
Tennoz Central Tower 6F, 2-2-24 Higashishinagawa, Shinagawa-ku, Tokyo, 140-0002, Japan
TEL
03-6711-5230
Homepage URL
m-nomura@jll.co.jp
Sponsor or person
Institute
Japan Lifeline Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
仙台市立病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center and prospective study
After implantation at 6-month and 12-month follow-up, conduct device check, BNP test, CTR measurement, NYHA class and confirm if any hospitalization due to heart failure
Management information
Registered date
| 2012 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008196
