Anastrozole in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— AIPH  

Official title:

A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545336
• Other study ID #: 815035
• Status: Completed
• Phase: Phase 2
• First received: February 29, 2012
• Last updated: December 3, 2015
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The main purpose of this clinical trial is to study the safety and efficacy of anastrozole in adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will also evaluate if anastrozole effects estradiol (E2) hormone levels, a sex hormone, and improves the function of the lower right chamber of the heart (right ventricle).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• 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 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:

• Treatment with estrogen or anti-hormone therapy (tamoxifen, fulvestrant, etc.)

• WHO Class IV functional status

• History of 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 echocardiography

• Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors) within three months of enrollment; the dose must be stable for at least 3 months prior to Baseline Visit

• Hormone therapy

• Hospitalized or acutely ill

• Renal failure (creatinine > 2.0)

• Child-Pugh Class C cirrhosis

• Current or recent (< 6 months) chronic heavy alcohol consumption

• Current use of another investigational drug (non-FDA approved) for PAH

• Enrollment in a clinical trial within one month of screening

• Age < 18

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Anastrozole
1 mg tablet to be taken 1 time daily
• Placebo
1 mg tablet to be taken 1 time daily

Locations

Country	Name	City	State
United States	University of Pennsylvania - Penn Presbyterian	Philadelphia	Pennsylvania
United States	University of Pennsylvania - Perelman Center	Philadelphia	Pennsylvania
United States	Brown University - Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effects of anastrozole vs. placebo on the plasma estradiol (E2)level		3 months	No
Primary	To assess the effects of anastrozole vs. placebo on tricuspid annular plane systolic excursion (TAPSE)		3 months	No