Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is greater than 3 times the upper limit of normal at the screening visit.Bosentan or sitaxsentan use within four weeks prior to the screening visit.Participation in a previous clinical study with ambrisentan.Male participants must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form. Female participants of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit.Right heart catheterization completed prior to screening must meet pre-specified criteria.Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor therapy.Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1) 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3) 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4) and 4) PH due to sarcoidosis (WHO Group 5).Participants could be receiving prostacyclin or sildenafil therapy at baseline, and participants who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities were eligible. Participants with left heart disease or left heart failure were excluded (WHO Group 2). This study was to enroll up to 200 participants with PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1) 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3) 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4) and 4) PH due to sarcoidosis (WHO Group 5). Why Should I Register and Submit Results?.With chronic diseases on the rise, our desire at SALT Health is to reverse the trend through preventative treatment right from the start. If we can get at the root of the problem right away through this preventative approach, we believe that we can reverse current healthcare trends by providing personalized care, lower risk interventions, and ultimately cost savings for patients in the long run. What is Functional Medicine and how does it improve healthcare? The Institute for Functional Medicine defines the functional medicine model as “an individualized, patient-centered, science-based approach that empowers patients and practitioners to work together to address the underlying causes of disease and promote optimal wellness.” More than 50,000 practitioners have been introduced to the principles and practices of functional medicine.Īnd how does this relate to SALT Health? Well, as a direct primary care facility, our entire mission is dedicated to the goals of getting to know each of our member patients on a deep and personal level so that we can determine the best possible care for them.
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