Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Previous documentation of mean pulmonary artery pressure > 25 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) < 16 mm Hg and PVR > 3 WU at any time before study entry. - Diagnosis of PAH which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection and receiving treatment for PAH. - Most recent pulmonary function tests with FEV1/FVC >50% AND either a) total lung capacity > 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest. - Ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination. - If female, post-menopausal state, defined as: - > 50 years old and a) have not menstruated during the preceding 12 months or b) have follicle-stimulating hormone (FSH) levels (> 40 IU/L) or - < 50 years and FSH (> 40 IU/L) or - having had a bilateral oophorectomy. - Informed consent.

Exclusion Criteria

  • Age < 18. - Current treatment with estrogen, hormone therapy, or anti-hormone therapy (tamoxifen, fulvestrant, etc.) - WHO Class IV functional status. - History of invasive breast cancer. - Clinically significant untreated sleep apnea. - Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction < 45% on most recent echocardiography (within 1 year). - Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors, riociguat, selexipag) within three months of enrollment; the dose must be stable for at least three months prior to Baseline Visit. PAH therapy which is stopped and then restarted or has dose changes which are not related to initiation and uptitration will be allowed within 3 months prior to the Baseline Visit. - Hospitalized or acutely ill. - Renal failure (creatinine ≥ 2.0). - Hypercalcemia. - Severe osteoporosis: T score -2.5 to -3.4 without bone modifying treatment OR T score = - 3.5 or lower - Child-Pugh Class C cirrhosis. - Current or recent (< 3 months) chronic heavy alcohol consumption. - Enrollment in a clinical trial or concurrent use of another investigational drug or device within 30 days of screening visit.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Anastrozole
1mg (1 tablet)taken by mouth once a day for one year
  • Drug: Anastrozole
    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.
    Other names:
    • Arimidex
Placebo Comparator
Placebo
1 tablet taken by mouth once a day for one year
  • Drug: Placebo Oral Tablet
    matching placebo tablet

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232
Contact:
Shannon Cordell, RN
615-343-8277
shannon.eason@Vanderbilt.Edu

More Details

Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Diane Pinder
215-294-9757
pinder@pennmedicine.upenn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.