UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052119 |
|---|---|
| Receipt number | R000059447 |
| Scientific Title | Assessment of tricuspid regurgitation by exercise stress echocardiography |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2024/03/19 11:56:29 |
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Basic information
Public title
Assessment of tricuspid regurgitation by exercise stress echocardiography
Acronym
Impact of Exercise Stress Echocardiography on Tricuspid Regurgitation
Scientific Title
Assessment of tricuspid regurgitation by exercise stress echocardiography
Scientific Title:Acronym
Impact of Exercise Stress Echocardiography on Tricuspid Regurgitation
Region
| Japan |
Condition
Condition
Tricuspid Valve Regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Secondary TR (STR) arises as a consequence of excessive right ventricular load, leading to right ventricular remodeling, annular dilation, and chordal tethering. This condition imposes a volume overload on the right heart, resulting in long-term severe cases manifesting right heart functional decline. Advanced regurgitation leads to decreased forward cardiac output into the right ventricle, often accompanied by symptoms such as dyspnea, fatigue, and generalized edema due to systemic venous congestion. Even in severe TR, symptoms can remain minimal over an extended period, which poses a problem by delaying surgical intervention. Hence, the consideration of invasive treatment without undue delay is imperative.
Therefore, this study aims to investigate STR patients and longitudinally measure exercise stress echocardiography to assess the contractile capability and systolic reserve of the right ventricle and elucidate their relationship with prognosis. Stress echocardiography is routinely performed in clinical practice as a diagnostic tool for valvular heart diseases, commonly used to evaluate the correlation between symptoms and valvular disease severity, as well as to assess cardiac reserve function. Although its utility is well-documented for aortic and mitral valve conditions, evidence regarding stress echocardiography in tricuspid valve diseases is scarce. In light of this, the study seeks to define exercise-based indicators and reserve capacity indices that determine the prognosis of STR. It aims to clarify whether there are instances where symptoms are genuinely absent in daily life and whether there might be a need for treatment even in asymptomatic cases. Ultimately, the research aims to address the optimal timing for intervention. As minimally invasive catheter-based treatments become increasingly widespread for STR cases, the importance of accurately determining the timing for managing STR is expected to grow, making this study highly significant.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study aims to assess mortality, heart failure readmissions, and the need for therapeutic interventions at 1, 3, and 5 years post-enrollment.
Key secondary outcomes
As secondary endpoints, we will investigate changes in the contractile and diastolic abilities of the left and right ventricles using transthoracic cardiac ultrasound examinations.
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Implementation of Exercise Stress Echocardiography in Tricuspid Valve Regurgitation
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Investigation involving exercise stress echocardiography in cases consenting to the study among patients diagnosed with tricuspid valve regurgitation.
Key exclusion criteria
Exclusion criteria encompass cases where exercise stress testing is deemed unfeasible or consent for participation has not been obtained.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kuwata |
Organization
St. Marianna University School of Medicine
Division name
Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
s2kuwata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kuwata |
Organization
St. Marianna University School of Medicine
Division name
Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
s2kuwata@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee of St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
Tel
044-977-8111
s2kuwata@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
| 2023 | Year | 09 | Month | 05 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059447
