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Recruiting NCT06753981

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

— Observational Arterial Pulmonary Hypertension (PAH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs.
Who it may be relevant to
Registry conditions: Arterial Pulmonary Hypertension (PAH). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Pulmonary Vascular Resistance (PVR) [Time frame: Up to 3 months]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical Univers — Jinan

Identifiers

NCT: NCT06753981 · YXLL-KY-2024 (124)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗