UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038678 |
|---|---|
| Receipt number | R000043918 |
| Scientific Title | Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease |
| Date of disclosure of the study information | 2019/11/26 |
| Last modified on | 2023/11/28 15:17:28 |
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Basic information
Public title
Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease
Acronym
Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease
Scientific Title
Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease
Scientific Title:Acronym
Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease
Region
| Japan |
Condition
Condition
left heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prognostic impact of LA function during exercise in left heart disease.
Basic objectives2
Others
Basic objectives -Others
To investigate the link between left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
hospitalization for HF/mortality
Key secondary outcomes
association between left atrial function and right ventricular-to-pulmonary circulation coupling during exercise.
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
1) Patients with left heart disease
2) Over 20 years old
3) Patients without mitral valve replacement
4) Patients without adult congenital heart disease
5) Patients without active myocardial ischemia
6) Patients without hypertrophic obstructive cardiomyopathy
7) Patients with agreement for the study
Key exclusion criteria
1) Patients with a prognosis of less than 12 months due to non-cardiac disease
2) Contraindication to exercise stress testing
3) Patients with poor echocardiographic image quality
4) Patients who are determined to be inappropriate for inclusion in the study by the principal investigator/shareholder
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadafumi |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Hospital
Division name
Department of Clinical Laboratory
Zip code
514-8507
Address
2-174 Edobashi, Tsu
TEL
059-232-1111
t_sugimoto_japan@hotmail.com
Public contact
Name of contact person
| 1st name | Tadafumi |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Hospital
Division name
Department of Clinical Laboratory
Zip code
514-8507
Address
2-174 Edobashi, Tsu
TEL
059-232-1111
Homepage URL
t_sugimoto_japan@hotmail.com
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu
Tel
059-232-1111
kk-sien@mo.medic.mie-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
| 2019 | Year | 11 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center prospective study to investigate the prognostic impact of left atrial function during exercise in left heart disease. The composite end point of hospitalization for heart failure/ all-cause mortality in 2 yearswas used as the primary outcome.
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043918
