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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Sulfasalazine is an anti-inflammatory and immunosuppressive drug
Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension
Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage
Renji Hospital
Shanghai, China
RECRUITINGTime to First Confirmed Clinical Adverse Event up to the End of Treatment
Clinical adverse event was defined as death.
Time frame: Up to end of treatment (data presented up to month 6)
Change From Baseline to Month 6 in 6-minute Walk Distance
The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
Time frame: Baseline to month 6
Change From Baseline to Month 6 in Inflammation Factor
Compose of Interleukin-6
Time frame: Baseline to month 6
Change From Baseline to Month 6 in Echocardiography Examination
Assessment of pulmonary artery systolic pressure by echocardiography
Time frame: Baseline to month 6
Change From Baseline to Month 6 in Cardiac Function
Compose of B-type natriuretic peptide
Time frame: Baseline to month 6
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Ambrisentan's placebo is similar to Ambrisentan in form and dosage