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Anastrozole in Patients With Pulmonary Arterial Hypertension (AIPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01545336
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : August 9, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Anastrozole Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension
Study Start Date : October 2012
Primary Completion Date : June 2015
Study Completion Date : September 2015


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Plasma Estradiol (E2) Level [ Time Frame: Baseline, 3 months ]
  2. Tricuspid Annular Plane Systolic Excursion (TAPSE) [ Time Frame: Baseline, 3 months ]

Secondary Outcome Measures :
  1. Six Minute Walk Distance [ Time Frame: Baseline, 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545336


Locations
United States, Pennsylvania
University of Pennsylvania - Penn Presbyterian
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University - Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Steven M Kawut, MD, MS University of Pennsylvania
More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01545336     History of Changes
Other Study ID Numbers: 815035
First Posted: March 6, 2012    Key Record Dates
Results First Posted: August 9, 2016
Last Update Posted: October 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs