Vanderbilt Clinical Trials

Pulmonary Hypertension and Anastrozole Trial

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

Pulmonary Arterial Hypertension

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

Arm	Description	Assigned 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

More Details

Status: Completed
Sponsor: University of Pennsylvania

Study Contact

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.