Anastrozole in Patients With Pulmonary Arterial Hypertension
AIPH
A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension
1 other identifier
interventional
18
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2012
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
August 9, 2016
CompletedOctober 27, 2016
September 1, 2016
2.7 years
February 29, 2012
June 29, 2016
September 20, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma Estradiol (E2) Level
Baseline, 3 months
Tricuspid Annular Plane Systolic Excursion (TAPSE)
Baseline, 3 months
Secondary Outcomes (1)
Six Minute Walk Distance
Baseline, 3 months
Study Arms (2)
Anastrozole
EXPERIMENTAL1 mg tablet by mouth once daily for 3 months
Placebo
PLACEBO COMPARATORPlacebo tablet by mouth once daily for 3 months
Interventions
1 mg tablet to be taken 1 time daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Pennsylvania - Penn Presbyterian
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, 19104, United States
Brown University - Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Related Publications (1)
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.
PMID: 27602993RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
* Small sample size * No changes in echo parameters * Unclear mechanism for impact on 6MWD
Results Point of Contact
- Title
- Dr. Steven M. Kawut
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Steven M Kawut, MD, MS
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 6, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
October 27, 2016
Results First Posted
August 9, 2016
Record last verified: 2016-09