Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study

NCT ID: NCT06753981

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2027-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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Arterial Pulmonary Hypertension (PAH)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-low-risk PAH treatment-naive patients

Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs

Intervention Type DRUG

Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs Including macitentan sildenafil/tadalafil or riociguat selexipag/epoprostenol.

Interventions

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Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs

Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs Including macitentan sildenafil/tadalafil or riociguat selexipag/epoprostenol.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Consent and sign the informed consent form
* Non-low-risk PAH treatment-naive patients

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Jianghan University Affiliated Hospital

UNKNOWN

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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GuanghaiWang

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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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, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guanghai Wang, Prof.

Role: CONTACT

Phone: +86 18553136966

Email: [email protected]

Facility Contacts

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Guanghai Wang

Role: primary

Other Identifiers

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YXLL-KY-2024 (124)

Identifier Type: -

Identifier Source: org_study_id