Effects of DHEA in Pulmonary Hypertension

Korábbi kezelés

• New background PAH therapy within 12 weeks
• Significant dose change in background PAH therapy within 12 weeks.
• Active or planned use of hormone supplements, oral contraceptive pills, hormonal therapies
• Current use of another investigational PAH therapy

Más betegség

• PAH associated with human immunodeficiency virus infection
• History of breast, ovarian, uterine, testicular or prostate cancer
• History of significant non-adherence or circumstance which would threaten ability to comply with cross-over design and study visit schedule

Laborértékek

• Evidence of left-sided valvular disease or systolic dysfunction on echocardiogram (≥ moderate mitral or aortic disease or LV ejection fraction ≤ 50%)

Életkor

• Age \< 18 years old

Egyéb

• Untreated severe obstructive sleep apnea diagnosed by polysomnography
• Glomerular filtration rate \<40 mls/min/1.73m2
• Child-Pugh Class C cirrhosis
• Untreated hypo- or hyper-thyroidism
• Pregnant or breastfeeding
• Contraindication to MRI (e.g., metal device or fragment)

• Diagnosis of PAH that is 1) idiopathic, 2) heritable or 3) associated with connective tissue disease, congenital systemic-to-pulmonary shunt, porto-pulmonary hypertension, drug or toxin use.
• Documentation of the following at any time prior to study entry:
• mPAP ≥ 25 mmHg at rest, pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg, and PVR \> 3 Wood units
• Pulmonary function testing documenting forced expiratory volume in one second/forced vital capacity ratio ≥ 70% predicted and total lung capacity ≥ 70% predicted
• If TLC is mildly reduced (60%\<TLC%\<70%), computerized tomography (HRCT or non-HRCT) documenting no significant interstitial lung disease may be used to fulfill this requirement.
• Chest tomography documenting no more than moderate parenchymal lung disease with clinician designated WHO I PAH and meeting both TLC and FEV1/FVC criteria.
• Normal or low probability V/Q scan
• If no V/Q scan is available, a CT angiogram documenting the absence of thromboembolic disease may be used, provided the subject meets diagnostic PAH criteria