UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034718 |
|---|---|
| Receipt number | R000039569 |
| Scientific Title | Novel Device-based Algorithm Could Obtain Optimal Hemodynamics During Exercise in Patients with Cardiac Resynchronization Therapy: Results of Exercise Stress Echocardiographic Optimization |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/05/12 16:31:22 |
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Basic information
Public title
Novel Device-based Algorithm Could Obtain Optimal Hemodynamics During Exercise in Patients with Cardiac Resynchronization Therapy: Results of Exercise Stress Echocardiographic Optimization
Acronym
ExerciseACRT
Scientific Title
Novel Device-based Algorithm Could Obtain Optimal Hemodynamics During Exercise in Patients with Cardiac Resynchronization Therapy: Results of Exercise Stress Echocardiographic Optimization
Scientific Title:Acronym
ExerciseACRT
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We Verified That Whether Device-based algorithm (AdaptivCRT) in cardiac resynchronization therapy Could Obtain Optimal Hemodynamics During Rest and Exercise in Patients with Cardiac Resynchronization Therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Echocardiography at Rest and Exercise Phase manually(aCRT off)and aCRT algorithm on
1.Trans Mitral Flow(in flow):E wave, A wave,DFT
2.LVOT-VTI
3.MR LV dP/dt
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Eligible patients were programmed optimal AV/VV delays manually (aCRT off) and aCRT algorithm on both at rest and exercise phase using the echocardiogram. We compared the maximum cardiac output using Doppler echocardiography at each phase.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients With Heart Failure Previously Implanted with Device Based Algorithm AdaptivCRT In Cardiac Resynchronization Therapy
Key exclusion criteria
The Patients May Do Not Underwent The Exercise Stress Echocardiography
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | ikutaro |
| Middle name | |
| Last name | nakajima |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology
Zip code
216-8511
Address
1-16-2 sugao miyamaeku kawasaki kanagwa
TEL
0449778111
ikutaro0817@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | akira |
| Middle name | |
| Last name | kasagawa |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology
Zip code
216-8511
Address
1-16-2 sugao miyamaeku kawasaki kanagwa
TEL
0449778111
Homepage URL
a2kasagawa@marianna-u.ac.jp
Sponsor or person
Institute
Division of Cardiology.St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology.St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Mariana University
Address
2-16-1sugao miyamaeku kawasakishi
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
聖マリアンナ医科大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31462585/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31462585/
Number of participants that the trial has enrolled
27
Results
there is no difference of LVOT-VTI adjusted auto adaptive system compared with manual echo guided optimization.
Results date posted
| 2023 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with CRT
Participant flow
We enrolled 27 patients with availability of the aCRT algorithm. Eligible patients were manually programmed
to optimal atrioventricular (AV) and interventricular (VV) delays by using echocardiograms at rest or during 2 stages of supine
bicycle exercise. We compared the maximum cardiac output between manual echo-optimization and aCRT-on during each phase.
Adverse events
none
Outcome measures
LVOT-VTI of TTE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039569
