Anastrozole in Patients With Pulmonary Arterial Hypertension

NCT ID: NCT01545336

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-09-30

Brief 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).

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Anastrozole

1 mg tablet by mouth once daily for 3 months

Group Type: EXPERIMENTAL

Anastrozole

Intervention Type: DRUG

1 mg tablet to be taken 1 time daily

Placebo

Placebo tablet by mouth once daily for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 mg tablet to be taken 1 time daily

Interventions

Anastrozole

1 mg tablet to be taken 1 time daily

Intervention Type: DRUG

Placebo

1 mg tablet to be taken 1 time daily

Intervention Type: DRUG

Other Intervention Names

Arimidex; Sugar pill manufactured to mimic Anastrozole 1 mg tablet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven M Kawut, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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, United States

Countries

United States

References

Kawut SM, Archer-Chicko CL, DeMichele A, Fritz JS, Klinger JR, Ky B, Palevsky HI, Palmisciano AJ, Patel M, Pinder D, Propert KJ, Smith KA, Stanczyk F, Tracy R, Vaidya A, Whittenhall ME, Ventetuolo CE. Anastrozole in Pulmonary Arterial Hypertension. A Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care Med. 2017 Feb 1;195(3):360-368. doi: 10.1164/rccm.201605-1024OC.

Reference Type: RESULT

PMID: 27602993 (View on PubMed)

Other Identifiers

815035

Identifier Type: -

Identifier Source: org_study_id