NCT04528056

Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.

Detailed description

Pulmonary arterial hypertension is characterized by decompensated increase of pulmonary artery pressure owing to continuous progression of pulmonary vascular resistance and can ultimately cause right heart failure even death. At present, the treatment of pulmonary arterial hypertension is mainly the application of specific drug therapy. Specific drug therapy involves the three major pathways of endothelin, nitric oxide and prostacyclin. The main mechanisms of vasodilation and anti-proliferation are used to treat pulmonary arterial hypertension. However, the price of specific drug therapy is too expensive, which puts huge financial pressure on patients. Evidence shows that inflammation exists in the early stages of pulmonary arterial hypertension and anti-inflammatory treatment is effective in animal experiments. Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Sulfasalazine	Sulfasalazine is an anti-inflammatory and immunosuppressive drug
DRUG	Ambrisentan	Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension
DRUG	Sulfasalazine's placebo	Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage
DRUG	Ambrisentan's placebo	Ambrisentan's placebo is similar to Ambrisentan in form and dosage

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-31
• Completion: 2022-10-31
• First posted: 2020-08-27
• Last updated: 2020-08-27

Locations

1 site across 1 country: China