NCT03229499已完成2 期
Pulmonary Hypertension and Anastrozole Trial (PHANTOM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 7
- 主要终点
- Change in Six-minute Walk Distance
研究概览
简要总结
The primary objectives of this study are to determine whether the study drug, anastrozole may improve six minute walk distance at six months compared to placebo and to assess safety and side effects up to twelve months in pulmonary arterial hypertension (PAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 PVR > 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 and receiving treatment for PAH.
- •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.
- •Ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination.
- •If 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.
排除标准
- •Current treatment with estrogen, hormone therapy, or anti-hormone therapy (tamoxifen, fulvestrant, etc.)
- •WHO Class IV functional status.
- •History of invasive 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 most recent echocardiography (within 1 year).
- •Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors, riociguat, selexipag) within three months of enrollment; the dose must be stable for at least three 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.
- •Hospitalized or acutely ill.
- •Renal failure (creatinine ≥ 2.0).
- •Hypercalcemia.
- •Severe osteoporosis: T score -2.5 to -3.4 without bone modifying treatment OR T score = - 3.5 or lower
- •Child-Pugh Class C cirrhosis.
- •Current or recent (< 3 months) chronic heavy alcohol consumption.
- •Enrollment in a clinical trial or concurrent use of another investigational drug or device within 30 days of screening visit.
研究组 & 干预措施
Anastrozole
Experimental
1mg (1 tablet)taken by mouth once a day for one year
干预措施: Anastrozole (Drug)
Placebo
Placebo Comparator
1 tablet taken by mouth once a day for one year
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in Six-minute Walk Distance
时间窗: 6 months
Change in the distance walked in six minutes adjusted for baseline value and sex
次要结局
- Change in Bone Mineral Density: Lumbar Spine Between Anastrozole and Placebo Groups(12 months)
- Change in Right Ventricular Function: Tricuspid Annular Systolic Plane Excursion (TAPSE)(6 months)
- Change in Plasma NT-proBNP(6months)
- Change in the Medical Outcomes Study Questionnaire Short Form-36 (SF36) Physical Component Summary (PCS) Score Adjusted for Baseline Value and Sex.(6months)
- Change in the emPHasis-10 Score Adjusted for Baseline Value and Sex(6months)
- Change in Actigraphy-measured Physical Activity: Change in 7-day Median Daily Vector Magnitude Count(6months)
- Number of Participants With a Clinical Worsening Event Between Anastrozole and Placebo Groups(12 months)
研究者
研究点 (7)
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