NCT07039604招募中不适用
Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)
Pulnovo Medical (Wuxi) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical worsening
研究概览
简要总结
Real-World Study of PADN for the Treatment of PAH
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PAH and received PADN procedure since March
- •No contraindications to procedure.
- •Able to provide informed consent and authorize use of health/research data.
- •Compliant with treatment and follow-up requirements.
排除标准
- •None specified.
结局指标
主要结局
Clinical worsening
时间窗: 1 year
Clinical worsening events defined as any of the following during the study period: 1. PAH-related rehospitalization. 2. Addition of PAH-targeted therapies (increased types/dose of PAH-targeted drugs or diuretics). 3. ≥10% or ≥30-meter reduction in 6-Minute Walk Distance (6MWD) from baseline. 4. Atrial septostomy. 5. Need for lung transplantation. 6. Cardiovascular death.
次要结局
- WHO Functional Class changes from baseline(6 months, 1, 2, 3, and 5 years)
- NT-proBNP/BNP levels from baseline(6 months, 1, 2, 3, and 5 years)
- 6MWD changes from baseline(6 months, 1, 2, 3, and 5 years)
- Incidence of pulmonary infections(Through study completion, an average of 5 years)
- All-cause death(Through study completion, an average of 5 years)
- Echocardiographic changes from baseline(6 months, 1, 2, 3, and 5 years)
研究者
研究点 (1)
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