At a glance
ClinicalIndex Comparison Record- ✓Documented mean pulmonary artery pressure >25 mmHg with pulmonary capillary wedge pressure <16 mmHg and pulmonary vascular resistance >3 WU at any time before study entry
- ✓PAH diagnosis: idiopathic, heritable, drug/toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection
- ✓Pulmonary function: FEV1/FVC >50% with total lung capacity >70% predicted OR 60-70% predicted with no more than mild interstitial lung disease on chest CT
- ✓Postmenopausal status: >50 years with no menses in preceding 12 months or FSH >40 IU/L, OR <50 years with FSH >40 IU/L, OR prior bilateral oophorectomy
- ✕Age <18 years
- ✕Current or prior estrogen or anti-hormone therapy (tamoxifen, anastrozole, etc.)
- ✕WHO Class IV functional status
- ✕History of breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension
In Brief
A Phase 2 clinical trial evaluating Fulvestrant for Pulmonary Arterial Hypertension. Completed, enrolled 5 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease.