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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambrisentan+Sulfasalazine | Experimental |
| |
| Ambrisentan+Sulfasalazine's placebo | Active Comparator |
| |
| Ambrisentan's placebo+Sulfasalazine | Experimental |
| |
| Ambrisentan's placebo+Sulfasalazine's placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfasalazine | Drug | Sulfasalazine is an anti-inflammatory and immunosuppressive drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Confirmed Clinical Adverse Event up to the End of Treatment | Clinical adverse event was defined as death. | Up to end of treatment (data presented up to month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieyan Shen, PhD | Contact | +8613701864819 | shenjieyan@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Jieyan Shen, PhD | Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012460 | Sulfasalazine |
| C467894 | ambrisentan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Ambrisentan | Drug | Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension |
|
| Sulfasalazine's placebo | Drug | Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage |
|
| Ambrisentan's placebo | Drug | Ambrisentan's placebo is similar to Ambrisentan in form and dosage |
|
| Baseline to month 6 |
| Change From Baseline to Month 6 in Inflammation Factor | Compose of Interleukin-6 | Baseline to month 6 |
| Change From Baseline to Month 6 in Echocardiography Examination | Assessment of pulmonary artery systolic pressure by echocardiography | Baseline to month 6 |
| Change From Baseline to Month 6 in Cardiac Function | Compose of B-type natriuretic peptide | Baseline to month 6 |
| Sulfur Compounds |