129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pulmonary Vascular Remodeling
研究概览
简要总结
The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).
详细描述
Subject Enrollment This study will consent and enroll 20 subjects total.
• For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled.
Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6MWD), will also collected at these timepoints.
Primary Study Endpoints The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Secondary Study Endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arm 1 -IPAH
- •Age: 18-75 years
- •WHO functional class 2 or 3
- •Mean pulmonary artery pressures > 20 mmHg
- •Pulmonary capillary wedge pressure ≤15 mmHg
- •Pulmonary vascular resistance > 2 Wood Units (WU)
- •No other cause identified for PAH
- •Arm 2 -PAH-CTD
- •Age: 18-75 years
- •WHO functional class (FC) 2 or 3
- •Mean pulmonary artery pressures > 20 mmHg
- •Pulmonary capillary wedge pressure ≤15 mmHg
- •Pulmonary vascular resistance > 2 WU
- •Diagnosis of connective tissue disease
排除标准
- •PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.
研究组 & 干预措施
Idiopathic Pulmonary Arterial Hypertension
Arm 1... patients with IPAH
干预措施: 129Xe Hyperpolarized (Drug)
Pulmonary Arterial Hypertension Associated with Connective Tissue Disease
Arm 2... patients with CTD-PAH
干预措施: 129Xe Hyperpolarized (Drug)
结局指标
主要结局
Pulmonary Vascular Remodeling
时间窗: 1 year
The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
次要结局
- RBC Oscillation Amplitude(1 year)
- 6 Minute Walk Distance(1 Year)
- NTproBNP(1 year)
- World Health Organization (WHO) Functional Class (FC)(1 year)
研究者
Bastiaan Driehuys
Professor of Radiology
Duke University