Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02911844 |
Date of registration:
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19/09/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension
ERA-PAH |
Scientific title:
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Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension |
Date of first enrolment:
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April 10, 2017 |
Target sample size:
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5 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02911844 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven M Kawut, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Key inclusion & exclusion criteria
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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
pulmonary vascular resistance > 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
- < 50 years and FSH > 40 IU/L or
- having had a bilateral oophorectomy.
- Informed consent.
Exclusion Criteria:
- Age < 18.
- Treatment with estrogen or anti-hormone therapy (tamoxifen, anastrozole, 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 or receptor agonists, endothelin-1
receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase
stimulators) within three months of enrollment; the dose must be stable for at least 3
months prior to Baseline Visit. PAH therapy which is stopped and then restarted or has
dose changes which are not related to initiation and uptitration will be allowed
within 3 months prior to the Baseline Visit.
- Hormone therapy.
- Use of warfarin or other anticoagulant (use of aspirin is permitted).
- Platelet count <100,000.
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Fulvestrant
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Primary Outcome(s)
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Change From Baseline of Tricuspid Annular Plane Systolic Excursion (TAPSE)
[Time Frame: Baseline to 9 weeks]
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Change From Baseline of Six Minute Walk Distance
[Time Frame: Baseline to 9 weeks]
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Change From Baseline of Plasma Estradiol Levels
[Time Frame: Baseline to 9 weeks]
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Change From Baseline of Plasma NT-proBNP Level
[Time Frame: Baseline to 9 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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