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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034718
Receipt No. R000039569
Official scientific title of the study 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 2018/10/31

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Basic information
Official scientific title of the study Novel Device-based Algorithm Could Obtain Optimal Hemodynamics During Exercise in Patients with Cardiac Resynchronization Therapy: Results of Exercise Stress Echocardiographic Optimization
Title of the study (Brief title) 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 IKUTARO NAKAJIMA
Organization St. Marianna University School of Medicine
Division name Division of Cardiology
Address 1-16-2 sugao miyamaeku kawasaki kanagwa
TEL 0449778111
Email ikutaro0817@marianna-u.ac.jp

Public contact
Name of contact person AKIRA KASAGAWA
Organization St. Marianna University School of Medicine
Division name Division of Cardiology
Address 1-16-2 sugao miyamaeku kawasaki kanagwa
TEL 0449778111
Homepage URL
Email a2kasagawa@marianna-u.ac.jp

Sponsor
Institute Division of Cardiology.St. Marianna University School of Medicine
Institute
Department

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)

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
2018 Year 11 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 31 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039569

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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