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

ConditionArterial Pulmonary Hypertension (PAH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorQianfoshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consent and sign the informed consent form

Non-low-risk PAH treatment-naive patients

Disqualifiers

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

Trial population

Adult patients with arterial pulmonary hypertension

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Non-low-risk PAH treatment-naive patients1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qianfoshan Hospital

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Jianghan University Affiliated Hospital

Collaborator

Source ClinicalTrials.gov
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