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

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Guanghai Wang, Prof.; Phone Number: +86 18553136966; Email: 224138908@qq.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • 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
      • Contact: Guanghai Wang; Phone Number: 18553136966; Email: 224138908@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with arterial pulmonary hypertension

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-low-risk PAH treatment-naive patients	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
N terminal pro B type natriuretic peptide （NT-proBNP）	Up to 3 months
6-minute walking distance	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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital; Jianghan University Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): February 14, 2027

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Vasodilator Agents; Antihypertensive Agents; Endothelin Receptor Antagonists; Epoprostenol; Tezosentan
• Other Study ID Numbers: YXLL-KY-2024 (124)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No