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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06753981

Enrollment

Registered

2024-12-31

Start date

2024-12-10

Completion date

2027-02-14

Last updated

2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Pulmonary Hypertension (PAH)

Brief 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.

Interventions

DRUGEndothelin 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pulmonary Vascular Resistance (PVR)	Up to 3 months

Secondary

Measure	Time frame
N terminal pro B type natriuretic peptide （NT-proBNP）	Up to 3 months
6-minute walking distance	Up to 3 months
Oxygen Saturation of Mixed Venose Blood (SvO2)	Up to 3 months
cardiac index (CI)	Up to 3 months
WHO Heart Function Classification	Up to 3 months
mean pulmonary arterial pressure (mPAP)	Up to 3 months

Countries

China

Contacts

Primary ContactGuanghai Wang, Prof.

224138908@qq.com+86 18553136966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026