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Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

Descriptive Information
Brief Title † Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension
Official Title † Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension
Brief Summary The main purpose of this clinical trial is to examine the feasibility and effects of fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will evaluate changes in circulating hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma biomarkers after the administration of fulvestrant. Changes in tricuspid annular plane systolic excursion, stroke volume index, right ventricular fractional area change, and other echo parameters after fulvestrant administration will be evaluated as well as changes in distance walked in six minutes.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Change in Plasma estradiol levels
Secondary Outcome Measure †
Condition † Pulmonary Arterial Hypertension
Intervention † DrugFulvestrant
Study Arms / Comparison Groups Fulvestrant 500 mg administered intramuscularly (as two 5 mL injections) on days 0, 14, 28 and 56
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 5
Start Date † April 10, 2017
Completion Date April 2018
Primary Completion Date April 2018
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) 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. - 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 - 40 IU/L or - having had a bilateral oophorectomy. - Informed consent. Exclusion Criteria: - Age /= 2.0). - Child-Pugh Class C cirrhosis. - Current or recent (
Gender Female
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Steven M Kawut, MD, 215-573-0258, kawut@upenn.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02911844
Organization ID 824861
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of Pennsylvania
Collaborators ††
Investigators † Principal Investigator: Steven M Kawut, MD, University of Pennsylvania
Information Provided By
Verification Date May 2017
First Received Date † September 19, 2016
Last Updated Date May 1, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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