Triple-targeted drug therapy for treatment-naive patients with arterial pulmonary hypertension
Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study
Qianfoshan Hospital · NCT06753981
This study is testing a new combination of three different medications for people with arterial pulmonary hypertension who are just starting treatment to see how well it works and how safe it is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06753981 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study investigates the efficacy and safety of a triple-targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The study aims to gather real-world data on the prognosis of these patients while they are treated with a combination of endothelin receptor antagonists, PDE5 inhibitors, and prostacyclin drugs. By focusing on treatment-naive patients, the study seeks to provide insights into the effectiveness of this therapeutic approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are treatment-naive patients diagnosed with non-low-risk arterial pulmonary hypertension.
Not a fit: Patients with positive acute vascular response tests, pulmonary veno-occlusive disease, or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with arterial pulmonary hypertension.
How similar studies have performed: While there is ongoing research in PAH treatment, this specific combination therapy approach in treatment-naive patients is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- 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 (RECRUITING)
Study contacts
- Study coordinator: Guanghai Wang, Prof.
- Email: 224138908@qq.com
- Phone: +86 18553136966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arterial Pulmonary Hypertension