The primary objectives of this study are to determine whether the study drug, anastrozole may improve six minute walk distance at six months compared to placebo and to assess safety and side effects up to twelve months in pulmonary arterial hypertension (PAH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Anastrozole is an aromatase inhibitor indicated for: * adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer * first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer * treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
matching placebo tablet
Stanford University
Stanford, California, United States
University of Colorado - Denver
Aurora, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Change in Six-minute Walk Distance
Change in the distance walked in six minutes adjusted for baseline value and sex
Time frame: 6 months
Change in Right Ventricular Function: Tricuspid Annular Systolic Plane Excursion (TAPSE)
Change in tricuspid annular systolic plane excursion (TAPSE) adjusted for baseline value and sex. TAPSE is a measure of right ventricular function that is measured via cardiac echography
Time frame: 6 months
Change in Plasma NT-proBNP
Change in log10 NT-proBNP adjusted for baseline value and sex
Time frame: 6months
Change in the Medical Outcomes Study Questionnaire Short Form-36 (SF36) Physical Component Summary (PCS) Score Adjusted for Baseline Value and Sex.
Change in the Medical Outcomes Study Questionnaire Short Form-36 (SF36) physical component summary (PCS) score adjusted for baseline value and sex. SF36 PCS score is a subjective measure of physical health status, with scores ranging from 0 to 100. Higher scores represent better health status.
Time frame: 6months
Change in the emPHasis-10 Score Adjusted for Baseline Value and Sex
Change in the emPHasis-10 score adjusted for baseline value and sex. EmPHasis-10 is a pulmonary hypertension-specific measure of quality of life which is scored from 0-50, with higher scores indicating worse quality of life.
Time frame: 6months
Change in Actigraphy-measured Physical Activity: Change in 7-day Median Daily Vector Magnitude Count
Actigraphy-measured vector magnitude count is an estimate of physical activity intensity. The total vector magnitude counts per day was measured over 7 days using an actigraphy device, and the median value over the 7 days was obtained. This outcome measure is the change in the 7-day median value from baseline to follow-up, adjusted for the baseline value, sex, and actigraphy device wear time.
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
East Providence, Rhode Island, United States
Vanderbilt University
Nashville, Tennessee, United States
Time frame: 6months
Number of Participants With a Clinical Worsening Event Between Anastrozole and Placebo Groups
Number of participants with a clinical worsening event. Clinical worsening was defined as the addition of new PAH therapies or dose increases in previously stable PAH therapy for increased symptoms, hospitalization for PAH progression and/or right-sided heart failure, lung transplantation, atrial septostomy, or all-cause death.' Unit of Measure is retained as 'Participants.
Time frame: 12 months
Change in Bone Mineral Density: Lumbar Spine Between Anastrozole and Placebo Groups
Change in lumbar spine bone mineral density adjusted for baseline value and sex between anastrozole and placebo groups
Time frame: 12 months