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Status:

COMPLETED

Pulmonary Hypertension and Anastrozole Trial

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Johns Hopkins University

Conditions:

Pulmonary Arterial Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 u...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 7 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 22 2022

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT03229499

Start Date

December 7 2017

End Date

July 22 2022

Last Update

May 1 2024

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Stanford University

Stanford, California, United States, 94305

2

University of Colorado - Denver

Aurora, Colorado, United States, 80045

3

Johns Hopkins University

Baltimore, Maryland, United States, 21218

4

Washington University

St Louis, Missouri, United States, 63130