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

Recruiting

• Conditions: Arterial Pulmonary Hypertension (PAH)
• Interventions: Drug: Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs

• Registration Number: NCT06753981
• Lead Sponsor: Qianfoshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-10
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2026-11-14
• Study Completion: 2027-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-low-risk PAH treatment-naive patients	Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs	-

Primary Outcome Measures

Name	Time	Method
Pulmonary Vascular Resistance (PVR)	Up to 3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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