Anastrozole in Patients With Pulmonary Arterial Hypertension (AIPH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01545336
First received: February 29, 2012
Last updated: August 4, 2014
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Anastrozole
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • To assess the effects of anastrozole vs. placebo on the plasma estradiol (E2)level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To assess the effects of anastrozole vs. placebo on tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anastrozole
1 mg tablet by mouth once daily for 3 months
Drug: Anastrozole
1 mg tablet to be taken 1 time daily
Other Name: Arimidex
Placebo Comparator: Placebo
Placebo tablet by mouth once daily for 3 months
Drug: Placebo
1 mg tablet to be taken 1 time daily
Other Name: Sugar pill manufactured to mimic Anastrozole 1 mg tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545336

Contacts
Contact: Mamta Patel, RN 215-662-9720 mamta.patel@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania - Penn Presbyterian Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mamta Patel, RN    215-662-9720    mamta.patel@uphs.upenn.edu   
Principal Investigator: Steven M Kawut, MD, MS         
University of Pennsylvania - Perelman Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mamta Patel, RN    215-662-9720    mamta.patel@uphs.upenn.edu   
United States, Rhode Island
Brown University - Rhode Island Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
Contact: Amy Palmisciano, RN, BSN    401-444-4961    apalmisciano@lifespan.org   
Principal Investigator: Corey Ventetuolo, MD, MS         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Steven M Kawut, MD, MS University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01545336     History of Changes
Other Study ID Numbers: 815035
Study First Received: February 29, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Anastrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014