Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung. The estimated prevalence is 30-80/100,000 in the United States with incidence estimates clearly rising. A major challenge in the care of patients with IPF is determining prognosis. The natural history of IPF is usually one of inexorable decline in lung function, ultimately resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF is heterogeneous and difficult to predict in individual patients. While some patients with IPF may remain stable for years, in others the disease may progress rapidly over a relatively short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and matrix-modifying molecules will improve prognostication in patients with IPF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-80 years, inclusive
- •Diagnosis of IPF by HRCT or surgical lung biopsy
- •Able to understand and provide informed consent
排除标准
- •AE-IPF during the prior year
- •Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.
- •Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.
- •Significant airway obstruction (FEV1/FVC ratio < 0.60) or bronchodilator response, defined as a change in FEV1 ≥ 12% and absolute change > 200 mL OR change in FVC ≥ 12% and absolute change > 200 mL at baseline
- •Partial pressure of arterial oxygen (PaO2) < 55 mm Hg
- •Evidence of active infection
- •Listed for lung transplantation
- •Myocardial infarction, coronary artery bypass, or angioplasty within 6 months
- •Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months
- •Uncontrolled arrhythmia or hypertension
- •Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis
- •Active substance and/or alcohol abuse
- •If you are pregnant or breastfeeding
- •Any condition other than IPF that is likely to result in your death within the next year
- •Any condition that, in the judgment of the PI, might cause participation in the study to be detrimental to you or that the PI deems makes you a poor candidate
结局指标
主要结局
Progression-free survival
时间窗: 1 year
The primary outcome is your progression free survival as determined by time until any of: death, acute exacerbation of IPF, relative decline in FVC (liters) of at least 10% or DLCO (ml/min/mmHg) of 15% from baseline.
次要结局
未报告次要终点
研究者
Eric S. White, MD
Professor of Internal Medicine
University of Michigan