Pulmonary HypertensionNCT05478226
ADAMTSL4 in Idiopathic Pulmonary Hypertension and CTEPH
An observational study of Pulmonary Hypertension, run by Wei Huang at 1 site in China.
Trial summary
ADAMTSL4 (A disintegrin and metalloproteinase with thrombospondin motifs like) is a member of the ADAMTSL family. ADAMTSL4 is one of the family of 7 ADAMTS-Like proteins, themselves part of the Thrombospondin type 1 repeat (TSR) superfamily of proteins. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- drugs or BPA
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with IPAH and CTEPH compliance with 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
Who may be able to join
- Healthy people，patients with IPAH，patients with CTEPH
Who cannot join
- tumour，infection，Pregnancy, suckling period， Mental disorders，
- Other types of PAH except CTEPH and IPAH
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: ADAMTSL4 in Idiopathic Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
ADAMTSL4 (A disintegrin and metalloproteinase with thrombospondin motifs like) is a member of the ADAMTSL family. ADAMTSL4 is one of the family of 7 ADAMTS-Like proteins, themselves part of the Thrombospondin type 1 repeat (TSR) superfamily of proteins. These 7 proteins are divided into two distinct clades, of which ADAMTSL4 and ADAMTS-Like 6 form part of one clade, differing from ADAMTS-Like 1, ADAMTS-Like 3 and ADAMTS-Like 7 by lacking immunoglobulin repeat regions. ADAMTSL4 is widely expressed in brain, colon, heart, kidney, liver, lung, pancreas and spleen, yet, its precise role is unclear. in addition, ADAMTSL4 protein high expression to the medial layer of the arterial wall, and medial vascular smooth muscle cells specifically.
Read the detailed description
The objectives of the present study aimed to confirm ADAMTSL4 levels in the proteomics between healthy control population and patients with IPAH，to analyze the expression levels of ADAMTSL4 between patients with IPAH and CTEPH, and to investigate whether serum levels of ADAMTSL4 might be used as biomarkers of disease severity in these patient populations.
- Conditions
- Pulmonary Hypertension
- Being tested
- drugs or BPA
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drugs or BPAOther
PAH target drugs，for example， Tadanafiland, Maxitensin, Prostacyclins, riociguat and etc. CTEPH treat with balloon pulmonary angioplasty or riociguat
| Study group | Role | What they receive |
|---|---|---|
| control group | healthy people as control group | |
| IPAH group | patients with IPAH as IPAH group Receives: Other: drugs or BPA | |
| CTEPH group | patients with CTEPH as CTEPH group Receives: Other: drugs or BPA | |
| group D | Including CTEPH group and IPAH group Receives: Other: drugs or BPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of clinic index and ADAMTSL4 expression level
The expression and its clinical relevance of ADAMTSL4 expression level in plasma or pulmonary tissue in patients with IPAH and CTEPH
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Jul 2018
- Primary completion31 Aug 2020
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Huang, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Wei Huang, Phd, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478226
- Sponsor's protocol ID
- 2019XMSB000726
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD is undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAMTSL4 in Idiopathic Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05478226
- Acronym / sponsor ID
- 2019XMSB000726
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Wei HuangUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ADAMTSL4 (A disintegrin and metalloproteinase with thrombospondin motifs like) is a member of the ADAMTSL family. ADAMTSL4 is one of the family of 7 ADAMTS-Like proteins, themselves part of the Thrombospondin type 1 repeat (TSR) superfamily of proteins. These 7 proteins are divided into two distinct clades, of which ADAMTSL4 and ADAMTS-Like 6 form part of one clade, differing from ADAMTS-Like 1, ADAMTS-Like 3 and ADAMTS-Like 7 by lacking immunoglobulin repeat regions. ADAMTSL4 is widely expressed in brain, colon, heart, kidney, liver, lung, pancreas and spleen, yet, its precise role is unclear. in addition, ADAMTSL4 protein high expression to the medial layer of the arterial wall, and medial vascular smooth muscle cells specifically.
Detailed description
The objectives of the present study aimed to confirm ADAMTSL4 levels in the proteomics between healthy control population and patients with IPAH，to analyze the expression levels of ADAMTSL4 between patients with IPAH and CTEPH, and to investigate whether serum levels of ADAMTSL4 might be used as biomarkers of disease severity in these patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | – | –healthy people as control group |
| IPAH group | – | Other: drugs or BPApatients with IPAH as IPAH group |
| CTEPH group | – | Other: drugs or BPApatients with CTEPH as CTEPH group |
| group D | – | Other: drugs or BPAIncluding CTEPH group and IPAH group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with IPAH and CTEPH compliance with 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
Key inclusion criteria (1 listed)
- Healthy people，patients with IPAH，patients with CTEPH
Key exclusion criteria (2 listed)
- tumour，infection，Pregnancy, suckling period， Mental disorders，
- Other types of PAH except CTEPH and IPAH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drugs or BPAPAH target drugs，for example， Tadanafiland, Maxitensin, Prostacyclins, riociguat and etc. CTEPH treat with balloon pulmonary angioplasty or riociguat | Other | CTEPH group, IPAH group, group D |
Primary outcome
Association of clinic index and ADAMTSL4 expression level
Time frame: 2018-2022
The expression and its clinical relevance of ADAMTSL4 expression level in plasma or pulmonary tissue in patients with IPAH and CTEPH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: Undecided. The IPD is undecided
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Huang, Phd principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Wei Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of clinic index and ADAMTSL4 expression level (time frame: 2018-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.