Clinical Trial: Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Summary:
Sponsor: University of Pennsylvania
Current Primary Outcome:
- Change in Plasma estradiol levels [ Time Frame: Baseline, 9 weeks ]
- Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) [ Time Frame: Baseline, 9 weeks ]
- Change in Six Minute Walk Distance [ Time Frame: Baseline, 9 weeks ]
- Change in Plasma NT-proBNP level [ Time Frame: Baseline, 9 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Pennsylvania
Dates:
Date Received: September 19, 2016
Date Started: April 10, 2017
Date Completion: April 2018
Last Updated: May 1, 2017
Last Verified: May 2017
