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NCT Number: NCT06753981

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.

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Key information

Conditions

Arterial Pulmonary Hypertension (PAH) Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 250014, China

Location status: Recruiting

Location contact

Guanghai Wang

CONTACT

[email protected]

18553136966

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Pulmonary Vascular Resistance (PVR)

    Time frame: Up to 3 months

Secondary outcomes

  1. N terminal pro B type natriuretic peptide （NT-proBNP）

    Time frame: Up to 3 months

  2. 6-minute walking distance

    Time frame: Up to 3 months

  3. mean pulmonary arterial pressure (mPAP)

    Time frame: Up to 3 months

  4. cardiac index (CI)

    Time frame: Up to 3 months

  5. WHO Heart Function Classification

    Time frame: Up to 3 months

  6. Oxygen Saturation of Mixed Venose Blood (SvO2)

    Time frame: Up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Guanghai Wang, Prof.

CONTACT

[email protected]

+86 18553136966

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Jianghan University Affiliated Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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