UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049130 |
|---|---|
| Receipt number | R000055965 |
| Scientific Title | Investigating the Usefulness of Physiological Heart Rate Response Sensors for Patients with Cardiac Resynchronization Therapy |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2022/10/19 17:50:43 |
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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
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
a2kasagawa@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055965
