Phase 2 Completed N=5 Treatment

Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Source: ClinicalTrials.gov NCT02911844 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcomePrimary: Change From Baseline of Plasma Estradiol Levels — -1.26 pg/ml

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline of Plasma Estradiol Levels	-1.26	—
PRIMARY Change From Baseline of Tricuspid Annular Plane Systolic Excursion (TAPSE)	2	—
PRIMARY Change From Baseline of Six Minute Walk Distance	31	—
PRIMARY Change From Baseline of Plasma NT-proBNP Level	42.1	—

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 (< 6 months) chronic heavy alcohol consumption.
Current use of another investigational drug (non-FDA approved) for PAH.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02911844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.