UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055583 |
|---|---|
| Receipt number | R000063517 |
| Scientific Title | Observational multicenter registry to DEvelop updaTed Echocardiographic Cut-off and algorithm for early deTection of Pulmonary Hypertension |
| Date of disclosure of the study information | 2024/09/22 |
| Last modified on | 2024/09/22 16:00:53 |
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Basic information
Public title
Observational multicenter registry to DEvelop updaTed Echocardiographic Cut-off and algorithm for early deTection of Pulmonary Hypertension
Acronym
DETECT-PH
Scientific Title
Observational multicenter registry to DEvelop updaTed Echocardiographic Cut-off and algorithm for early deTection of Pulmonary Hypertension
Scientific Title:Acronym
DETECT-PH
Region
| Japan |
Condition
Condition
Patients who underwent right heart catheterization
Classification by specialty
| Medicine in general | Cardiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the new criteria for pulmonary hypertension proposed in the ESC/ERS 2022 guidelines, as well as the echocardiographic indicators useful for screening pulmonary arterial hypertension and their reference values. Additionally, it will investigate whether past indicators and the diagnostic indicators established through this study are associated with patient prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The positivity rate of echocardiographic indicators in cases with mean pulmonary artery pressure greater than 20 mmHg as measured by right heart catheterization.
The positivity rate of echocardiographic indicators in cases with mean pulmonary artery pressure greater than 20 mmHg, pulmonary artery wedge pressure less than or equal to 15 mmHg, and pulmonary vascular resistance greater than 2 WU as measured by right heart catheterization.
Key secondary outcomes
Correlation between right heart catheterization indicators and echocardiographic indicators.
Occurrence of cardiovascular events during the follow-up period.
Occurrence of all-cause mortality during the follow-up period.
Interventions for pulmonary hypertension during the follow-up period.
Physical findings: Changes in WHO/NYHA functional class, 6-minute walk distance, and cardiopulmonary exercise test results from baseline to the end of the observation period.
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
1. Patients aged 18 years or older at the time of enrollment
2. Patients who underwent echocardiography within 48 hours before or after the right heart catheterization
Key exclusion criteria
1. Patients who received treatment interventions that could affect hemodynamics between the echocardiography and right heart catheterization (such as dialysis, medication administration, etc.)
2. Patients for whom echocardiography could not be performed within 48 hours before or after the right heart catheterization due to scheduling constraints or the clinical system
3. Patients who requested to withdraw from the study or revoked their consent
4. Patients deemed unsuitable for the study by the principal investigator for any other reason
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kimi |
| Middle name | |
| Last name | Sato |
Organization
University of Tsukuba Hospital
Division name
Department of Cardiovascular Medicine
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki, Japan
TEL
029-853-3143
kimisato@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kimi |
| Middle name | |
| Last name | Sato |
Organization
University of Tsukuba Hospital
Division name
Department of Cardiovascular Medicine
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki, Japan
TEL
029-853-3143
Homepage URL
kimisato@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Japanese Society of Echocardiography
IRB Contact (For public release)
Organization
University of Tsukuba Hospital, Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki, Japan
Tel
029-853-3900
rinshokenkyu@un.tsukuba.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
(1) 筑波大学附属病院（茨城県）
(2) 群馬大学医学部附属病院（群馬県）
(3) 兵庫医科大学（兵庫県）
(4) 国立循環器病研究センター（大阪府）
(5) 順天堂大学医学部附属順天堂医院（東京都）
(6) 宮崎市郡医師会病院（宮崎県）
(7) 愛知医科大学（愛知県）
(8) 東邦大学医療センター大橋病院（東京都）
(9) 琉球大学病院（沖縄県）
(10) 日本大学医学部附属板橋病院（東京都）
(11) 岐阜大学医学部附属病院（岐阜県）
(12) 三重大学病院（三重県）
(13) 手稲渓仁会病院（北海道）
(14) 鳥取大学医学部附属病院（鳥取県）
(15) 徳島大学病院（徳島県）
(16) 高松市立みんなの病院（香川県）
(17) 名古屋市立大学大学院医学研究科（愛知県）
(18) 宮崎大学医学部附属病院（宮崎県）
(19) 聖マリアンナ医科大学病院（神奈川県）
(20) 呉共済病院（広島県）
(21) 山梨大学医学部附属病院（山梨県）
(22) 藤田医科大学（愛知県）
(23) 国立国際医療研究センター病院（東京都）
(24) 産業医科大学病院（福岡県）
(25) 東京医科大学病院（東京都）
(26) 国立病院機構岡山医療センター（岡山県）
(27) 広島大学病院（広島県）
(28) 神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 22 | 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 | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will conduct both retrospective and prospective research targeting cases where right heart catheterization was performed as part of routine clinical care. This study does not involve any interventions, and all collected data, including test information, will be obtained within the scope of standard medical care. The subjects of the retrospective study will be patients who underwent catheterization between 2021 and 2023. In the prospective study, echocardiography will, in principle, be performed on the same day as the catheterization (or within 48 hours, plus or minus, at most).
Management information
Registered date
| 2024 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063517
