A Randomised, Single-blind, Sham Operation-controlled Study to Evaluate the Safety and Efficacy of the Pulmonary Artery Denervation for the Treatment of Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month
研究概览
简要总结
The objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of PADN for the treatment of PAH.
详细描述
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in 6-minute walk distance (6MWD) of PADN on PAH patients. Based on the previous studies, the 6MWD was 13±24 m after 6-month treatment using target drugs. And our previous data showed that 6MWD at 6-month after PADN procedure was 65±85 m. As a result, a total of 128 patients with Group I PAH are randomized at a ratio of 1:1 to either PADN procedure plus phosphodiesterase-5 inhibitors (PDE5i) group (PADN group) or sham-PADN procedure plus PDE5i group (Sham group) using a randomization schedule blocked by site. The combination therapy of PDE5i with additional other PAH-specific target drugs is not recommended for all patients and is left at physician's discretion in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
sham operation
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
- •Provision of informed consent prior to any study specific procedures; Men and women 18 years and older; Group I PAH, defined as a mPAP≥25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.
排除标准
- •General exclusion criteria:
- •Pregnancy and breast feeding mother; Estimated life expectancy < 12 months; Scheduled major surgery in the next 6 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.
- •Procedural exclusion criteria:
- •WHO group II, III, IV, V PH Severe Renal dysfunction (Ccr<30 ml/min) Blood platelet count<100,000/L Expected life span<6-month Systematical inflammation Malignant cancer(s) Tricuspid valve stenosis, Supra-pulmonary valve stenosis Allergic to studied drugs or metal materials.
结局指标
主要结局
Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month
时间窗: Baseline, 6 Month
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
次要结局
- Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 6 Month(Baseline, 6 Month)
- Change From Baseline in Cardiac Output (CO) at 6 Month(Baseline, 6 Month)
- Change From Baseline in Right Ventricle Functional at 6 Month(Baseline, 6 Month)
- Change From Baseline in Pulmonary Vascular Resistance (PVR) at 6 Month(Baseline, 6 Month)
- PAH-related events(6 Month)
- Change From Baseline in Systolic Pulmonary Arterial Pressure (sPAP) at 6 Month(Baseline, 6 Month)
- Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at 6 Month(Baseline, 6 Month)
研究者
Hang Zhang
Vice Director of Cardiovascular Department
Nanjing First Hospital, Nanjing Medical University