Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prediction of one year mortality
研究概览
简要总结
Prospective observational study to determine if the PVD-B65 risk score for one-year mortality in patients with chronic lung disease and pulmonary hypertension (CLD-PH) can accurately risk stratify these patients and successfully predict one-year mortality from time of pulmonary hypertension diagnosis. PVD-B65 risk score was developed in a retrospective cohort of patients with CLD-PH, utilizing the presence of pulmonary fibrosis without emphysema, pulmonary vascular resistance (PVR) > 5 woods units (WU), 6-minute walk distance (6MWD) < 150 meters, B-natriuretic type peptide (BNP) > 200 pg/mL or N-terminal pro-natriuretic type peptide (NT-proBNP) > 300 pg/dL, and age > 65 years as the score components.
详细描述
Objectives:
Primary objective: Prospectively validate the PVD-B65 risk score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension by assigning a PVD-B65 score at time of diagnosis and/or referral and following one-year mortality outcome.
Secondary objectives:
- Assess whether the risk severity assigned from the PVD-B65 score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension can predict clinical worsening.
- Assess whether optimal treatment in line with standard of care of both chronic lung disease and pulmonary hypertension can modify the initial risk severity assigned from the PVD-B65 score and in turn influence survival outcomes.
Primary endpoint: One-year outcome of mortality vs. lung transplantation vs. alive without lung transplantation
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria
- •Adult patients ≥ 18 years of age with chronic lung disease diagnosed via CT chest and/or PFT data and pre-capillary pulmonary hypertension diagnosed via right-heart catheterization (RHC, mPAP > 20 mmHg, PVR > 2 WU, and PCWP ≤ 15 mmHg)
- •Chronic lung disease diagnoses will include: COPD, IPF, other pulmonary fibrosis, non-fibrotic ILD, combined pulmonary fibrosis and emphysema, and advanced pulmonary sarcoidosis with parenchymal involvement
- •PFT criteria will include an FEV1/FVC < 0.70 for the diagnosis of COPD
- •Willingness to make return visits and be available by telephone for the duration of the study.
- •Ability to participate in necessary testing, including ambulatory testing
排除标准
- •Exclusion criteria
- •Patients with pulmonary hypertension but without associated chronic lung disease (i.e. idiopathic or group 1 PAH, PH with post-capillary component defined as PCWP > 15 mmHg or group 2 PAH, CTEPH or group 4 PH, group 5 PH aside from sarcoidosis with parenchymal involvement)
- •Patients with uncontrolled severe systemic disease that could influence life expectancy (i.e. uncontrolled cardiovascular disease, active malignancy, etc.)
- •Prior lung and/or heart transplantation
结局指标
主要结局
Prediction of one year mortality
时间窗: One year
death (yes or no)
次要结局
- Clinical worsening(one year)
- Change in PH severity via RHC(Assessed every 6 months for one year)
- Change in functional status(Assessed every 3 months for one year)
- Change in PH severity via TTE(Assessed every 3 months for one year)
- Change in PVD-B65 score and associated risk severity through duration of study(Every 3 months for one year)