UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055392 |
|---|---|
| Receipt number | R000063300 |
| Scientific Title | Relationship between preload and cardiac output in right ventricular dysfunction |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/08/20 07:04:17 |
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Basic information
Public title
Relationship between preload and cardiac output in right ventricular dysfunction
Acronym
RIGHT study
Scientific Title
Relationship between preload and cardiac output in right ventricular dysfunction
Scientific Title:Acronym
RIGHT study
Region
| Japan |
Condition
Condition
Right ventricular failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between hemodynamic parameters and cardiac output in right ventricular dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between right atrial pressure (central venous pressure) and cardiac output
Key secondary outcomes
The relationship between other hemodynamic parameters (blood pressure, heart rate, pulmonary pressure, right ventricular pressure, pulmonary artery wedge pressure) and cardiac output.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pulmonary artery pulse index ([systolic PAP-diastolic PAP]/CVP) <1.85 and CVP/PAWP >0.63. PAP=pulmonary artery pressure; PAWP=pulmonary artery wedge pressure; CVP=central venous pressure.
Key exclusion criteria
Patients with left ventricular ejection fraction <50% (except for patients with left ventricular assist device), severe left-sided valvular disease, congenital heart disease, or cardiac shunt.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
81-263-37-3486
jersey0042@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
81-263-37-3486
Homepage URL
jersey0042@gmail.com
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University Institutional Review Board
Address
3-1-1 Asahi, Matsumoto, Japan
Tel
81-263-37-2572
mdrinri@shinshu-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
| 2024 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 08 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063300
