Arterial Pulmonary Hypertension (PAH)NCT06753981
Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study
An observational study of Arterial Pulmonary Hypertension (PAH), run by Qianfoshan Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The prognosis of arterial pulmonary hypertension is explored. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Pulmonary Hypertension (PAH)
- What is being tested?
- Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 14 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with arterial pulmonary hypertension
Who may be able to join
- Consent and sign the informed consent form
- Non-low-risk PAH treatment-naive patients
Who cannot join
- Positive acute vascular response test for idiopathic/hereditary/drug-related arterial pulmonary hypertension
- Pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (PVOD/PCH) with arterial pulmonary
- Pregnant or lactating women
- Suffering from mental illness or cognitive impairment
- PAH patients with concurrent malignant tumors
- Patients with moderate to severe hepatic impairment, renal impairment, and severe anemia
- Currently participating in other interventional clinical studies
- Key clinical data is incomplete, or the investigator considers that the patient has other factors that make them unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
Jinan, Shandong, 250014
Guanghai Wang, 18553136966, 224138908@qq.com
About this study
This study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The prognosis of arterial pulmonary hypertension is explored.
- Conditions
- Arterial Pulmonary Hypertension (PAH)
- Being tested
- Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugsDrug
Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs Including macitentan sildenafil/tadalafil or riociguat selexipag/epoprostenol.
| Study group | Role | What they receive |
|---|---|---|
| Non-low-risk PAH treatment-naive patients | Not described Receives: Drug: Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vascular Resistance (PVR)
Measured: Up to 3 months
Secondary outcomes (6)
N terminal pro B type natriuretic peptide （NT-proBNP）
Measured: Up to 3 months
6-minute walking distance
Measured: Up to 3 months
mean pulmonary arterial pressure (mPAP)
Measured: Up to 3 months
cardiac index (CI)
Measured: Up to 3 months
WHO Heart Function Classification
Measured: Up to 3 months
Oxygen Saturation of Mixed Venose Blood (SvO2)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start10 Dec 2024
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Pulmonary Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Jianghan University Affiliated Hospital
- Responsible party
- Principal investigator, GuanghaiWang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753981
- Sponsor's protocol ID
- YXLL-KY-2024 (124)
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study
- ClinicalTrials.gov ID
- NCT06753981
- Acronym / sponsor ID
- YXLL-KY-2024 (124)
- Conditions
- Arterial Pulmonary Hypertension (PAH)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Jianghan University Affiliated Hospital
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 31 Dec 2024 (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.
This study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The prognosis of arterial pulmonary hypertension is explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-low-risk PAH treatment-naive patients | – | Drug: Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with arterial pulmonary hypertension
Key inclusion criteria (2 listed)
- Consent and sign the informed consent form
- Non-low-risk PAH treatment-naive patients
Key exclusion criteria (8 listed)
- Positive acute vascular response test for idiopathic/hereditary/drug-related arterial pulmonary hypertension
- Pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (PVOD/PCH) with arterial pulmonary
- Pregnant or lactating women
- Suffering from mental illness or cognitive impairment
- PAH patients with concurrent malignant tumors
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 |
|---|---|---|
| Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugsEndothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs Including macitentan sildenafil/tadalafil or riociguat selexipag/epoprostenol. | Drug | Non-low-risk PAH treatment-naive patients |
Primary outcome
Pulmonary Vascular Resistance (PVR)
Time frame: Up to 3 months
6 secondary outcomes
N terminal pro B type natriuretic peptide （NT-proBNP）
Time frame: Up to 3 months
6-minute walking distance
Time frame: Up to 3 months
mean pulmonary arterial pressure (mPAP)
Time frame: Up to 3 months
cardiac index (CI)
Time frame: Up to 3 months
WHO Heart Function Classification
Time frame: Up to 3 months
Oxygen Saturation of Mixed Venose Blood (SvO2)
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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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.
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 Arterial Pulmonary Hypertension (PAH), run by Qianfoshan Hospital 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanghai Wang, Prof. (+86 18553136966, 224138908@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Vascular Resistance (PVR) (time frame: Up to 3 months). 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 31 Dec 2024.