Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 10
- 主要终点
- Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization
研究概览
简要总结
Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.
The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.
The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.
The study will run for 18 months and it will be necessary to recruit 50 patients.
All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.
The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers 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)
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
- •Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension)
- •Aged over 18 years old
- •NYHA class III or IV
- •Not controlled by optimal medical management as defined by:
- •dual therapy including a prostacyclin.
- •or dual therapy including an endothelin receptor antagonist and a
- •5-phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal.
- •Valid status in the social security system
- •Signed informed consent
排除标准
- •Patient eligible for pulmonary transplantation
- •Pregnancy or breastfeeding
- •Adults of the age of majority subject to guardianship court order or deprived of liberty
- •Patient with history of radio frequency procedure
- •Known heparin allergy
结局指标
主要结局
Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization
时间窗: at 6 month
次要结局
- Mean pulmonary artery pressure (in mmHg) from the initial procedure(at 3 month)
- Pulmonary vascular resistance (in Wood units) measured during right cardiac catheterization.(at 6 month)
- Clinical parameters: 6-minute walk test (distance walked in meters),(at 6 month)
- Clinical parameters: Borg dyspnea rating scale(at 6 month)
- Clinical parameters: oxygen dependence (quantity of oxygen in L/min),(at 6 month)
- Biological parameters: levels of Brain Natriuretic Peptide (pg/ml) in non-fasting morning samples.(at 6 month)
- Other hemodynamic parameters obtained by right cardiac catheterization(at 6 month)
- Biological parameters: levels of troponin Ic (ng/ml) in non-fasting morning samples.(at 6 month)
- Clinical parameters: ECG with supra ventricular arrhythmia.(at 6 month)
- Echocardiographic parameters of right ventricular function(at 6 month)
- Clinical parameters: NYHA class(at 6 month)