NCT06753981
Recruiting
Not Applicable
Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study
Qianfoshan Hospital1 site in 1 country48 target enrollmentDecember 10, 2024
ConditionsArterial Pulmonary Hypertension (PAH)
Overview
- Phase
- Not Applicable
- Intervention
- Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs
- Conditions
- Arterial Pulmonary Hypertension (PAH)
- Sponsor
- Qianfoshan Hospital
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pulmonary Vascular Resistance (PVR)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
GuanghaiWang
Dr.
Qianfoshan Hospital
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.
Arms & Interventions
Non-low-risk PAH treatment-naive patients
Intervention: Endothelin receptor antagonist (ERA) combined with PDE5i/sGC agonist dual therapy prostacyclin drugs
Outcomes
Primary Outcomes
Pulmonary Vascular Resistance (PVR)
Time Frame: Up to 3 months
Secondary Outcomes
- 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)
Study Sites (1)
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