UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050461 |
|---|---|
| Receipt number | R000053828 |
| Scientific Title | A Cross-sectional study, whether parathyroid hormone (PTH) correlates with pulmonary hypertension. |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2026/03/25 11:32:36 |
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Basic information
Public title
A Cross-sectional study, whether parathyroid hormone (PTH) correlates with pulmonary hypertension.
Acronym
A Cross-sectional study, whether parathyroid hormone (PTH) correlates with pulmonary hypertension.
Scientific Title
A Cross-sectional study, whether parathyroid hormone (PTH) correlates with pulmonary hypertension.
Scientific Title:Acronym
A Cross-sectional study, whether parathyroid hormone (PTH) correlates with pulmonary hypertension.
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary hypertension (PH) is a severe syndrome of right heart failure and has a severe prognosis. Recently, many vasodilator drugs were developed and improved survival rate, however it is unknown to detail mechanism for PH pathology.Recent studies have suggested that PTH also acts on the cardiovascular system and affects cardiovascular prognosis. We hypothesized that PTH would play a role in the pathogenesis of PH.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.age,sex,diagnosis
2.serological tests (with intact PTH)
3.UCG
4.right heart hemodynamics by catheter
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PH patients and patients who were suspected of PH.
Key exclusion criteria
Exclusion criteria are under 18 year old, chronic renal disease (eGFR<50), left heart diseases (group2 PH), past history with cancer and treated with drugs influence for bone metabolism.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Joki |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-3813-3111
yjyouki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Joki |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-3813-3111
Homepage URL
yjyouki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School of Medicine
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
Juntendo University Graduate School of Medicine
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
81-3-3813-3111
yjyouki@juntendo.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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.125.327401
Number of participants that the trial has enrolled
30
Results
30 participants were enrolled in this study, of whom 22 were diagnosed with pulmonary hypertension (PH). The underlying etiologies of PH included idiopathic pulmonary arterial hypertension (n=5), connective tissue disease-associated PH (n=10), and chronic thromboembolic PH (n=7). PTH levels showed significant positive correlations with pulmonary hemodynamic parameters. Receiver operating characteristic analysis identified a PTH cut-off value of 46.0 pg/mL for predicting PH.
Results date posted
| 2026 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This cross-sectional study included patients with PH or suspected PH who underwent right heart catheterization between February 2019 and May 2022 at Juntendo University. Baseline characteristics, including age, sex, medical history, medications, and echocardiographic parameters were collected from medical records. Exclusion criteria were age under 18 years, chronic kidney disease, left heart disease, and a history of cancer.
Participant flow
Patients with PH or suspected PH who underwent right heart catheterization at a single center were screened. After applying exclusion criteria, 30 participants were enrolled. Of these, 22 were diagnosed with PH and 8 were classified as non-PH. Measurement of 25(OH)D was not available in one patient due to insufficient serum sample.
Adverse events
none
Outcome measures
The primary outcome was the association between serum PTH levels and pulmonary hemodynamic parameters (mPAP and PVR).Secondary outcomes included the relationships between PTH and clinical parameters such as cardiac index (CI), proBNP, and uric acid, as well as the diagnostic performance of PTH for predicting PH assessed by receiver operating characteristic analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053828
