Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tufts Medical Center
With
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects need to fulfill all of the following 4 criteria:
1. Evidence of portal hypertension (by hemodynamic measurement, or by Doppler flow of portal circulation, or by clinical evidence of portal hypertension such as esophageal or gastric varices, as evidenced by prior upper endoscopy).
2. Evidence of pulmonary arterial hypertension by right heart catheterization (all three criteria need to be present) Right heart catheterization may have been performed up to 30 days prior to screening
* Mean PAP (pulmonary artery pressure) \>25 mm Hg, and
* PVR (pulmonary vascular resistance) \>240 dynes/s/cm5, and
* TPG (transpulmonary gradient = meanPAP -PAWP) \>12 mm Hg
3. Baseline AST, ALT \< 5 times the upper limit of normal, total Bili \< 3.0 mg/dl, and mild liver impairment with Child -Pugh class A or B
4. Ages 18 years and above
You may not be if
1. Presence of any other etiology of pulmonary arterial hypertension (HIV, connective tissue disease, sickle cell, left heart failure, chronic thromboembolic PH, etc)
2. Treatment with prostacyclins, other ERAs, or PDE5 inhibitors within 30 days of enrollment.
3. Moribund state or anticipated death within 1 month.
4. AST or ALT ≥ 5 times upper limit of normal
5. Total bilirubin ≥ 3.0 mg/dl
6. Significant lung disease (obstructive lung disease with FEV1 \< 1L, or FEV1/FVC \<50%; or restrictive lung disease with Total Lung Capacity \< 60% predicted). PFTs may have been performed up to 6 months prior to enrollment.
7. Pregnancy
8. Age \<18 years
9. Child -Pugh class C
Clareo Health | Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial
