NCT05339386已完成不适用
Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in RBC/Membrane Ratio
研究概览
简要总结
In this study, hyperpolarized 129Xe MRI will be used to evaluate treatment efficacy in patients with pulmonary arterial hypertension (PAH). Participants will be imaged at 4 timepoints (baseline, 6 weeks post-therapy initiation, 12 weeks, and 18 weeks). Images will be analyzed to develop new biomarkers and to understand treatment effects.
详细描述
- Optimize Xe-MRI Oscillation Imaging for PAH. Regional mapping of oscillations in the xenon RBC signal is a new technique that may provide new insights into microvascular function in PH. Recent innovations in Xe-MRI have enabled improvements to this methodology, but these have yet to be explored and optimized.
- Quantify the short- and long-term repeatability of Xe-MRI oscillation imaging in patients with PAH. Hyperpolarized 129Xe oscillation imaging is a novel technique that may provide regional quantification of pulmonary microvascular function. However, the repeatability of this technique has not been measured, which limits its use as an outcome measure.
- Determine the minimum time-point at which Xe-MRI shows a clinically meaningful change following treatment. Current standards in the PAH community are to assess treatment efficacy in PAH patients at 3-6 months using 6MWTs, REVEAL Lite scores, echocardiograms, and possibly RHCs. However, Xe-MRI may be more sensitive to functional improvements. We hypothesize that Xe-MRI biomarkers will show a clinically meaningful change within 12 weeks of initiation of pulmonary vasodilators.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age
- •Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
- •Idiopathic PAH
- •Heritable PAH
- •Drug/toxin-induced PAH
- •PAH associated with CTD
- •Symptomatic PAH classified as WHO FC I, II, or III.
- •Documented Historical RHC with a mPAP ≥ 20 mmHg, PCWP ≤15 mmHg, and PVR ≥ 3 Wood Units (WU)
- •Ability to adhere to the study visit schedule, adhere, and comply with all protocol requirements.
- •Ability to understand and provide written informed consent.
- •For patients in the Initiating Therapy Arm:
- •Initiation of pulmonary vasodilator therapy within ±3 weeks of baseline imaging timepoint.
- •For patients in the Stable Arm:
- •On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice
排除标准
- •Subject unable to undergo MRI based on MRI safety screening
- •Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- •Pregnant or breastfeeding female subjects
- •Prisoners or incarcerated individuals
- •Any major surgical procedure within 90 days prior to study enrollment or planned surgical procedure during the study period.
- •Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study
- •Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of the study
研究组 & 干预措施
Initiating Therapy
PAH patients who are newly initiating background therapy to treat pulmonary arterial hypertension.
干预措施: Hyperpolarized Xe129 (Drug)
Stable
PAH patients who are stable on therapy (On stable doses of background PAH therapy and diuretics for at least 90 days prior to screening).
干预措施: Hyperpolarized Xe129 (Drug)
结局指标
主要结局
Change in RBC/Membrane Ratio
时间窗: 18 weeks
Absolute change over 4 imaging timepoints of RBC/Membrane Ratio from xenon MRI.
次要结局
- Change in Xenon RBC oscillation amplitude(18 weeks)
- Change in Xenon RBC uptake(18 weeks)
研究者
研究点 (2)
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