A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Clinical Worsening, defined as the occurrence of any of the followings:
研究概览
简要总结
It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.
详细描述
Chronic heart failure (CHF) patients who have received guideline-directed medical therapy (GDMT) based on the 2023 ESC Guidelines for HF and have reached clinical stable, and diagnosed with PH-LHD by right heart catheterization, will be randomized to the PADN group or control group in a 1:1 ratio to receive PADN combined with HF GDMT or HF GDMT, respectively. After the 12-month follow-up visit is completed, participants in the control group who still meet the inclusion and exclusion criteria can also choose to receive PADN.
Approximately 264 participants will be enrolled at up to 39 centers in China and followed for 3 years. The safety and efficacy of the PADN system, including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group.
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 (Outcomes Assessor)
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
- •Age ≥18, ≤75 years old;
- •Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
- •Clinically stable defined by
- •No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
- •Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg and resting heart rate (HR) ≥50 and <100 bpm (<110 bpm for atrial fibrillation) on the day of the procedure
- •New York Heart Association (NYHA) class II-IVa;
- •6MWD ≥ 100 m and < 450 m;
- •NT-proBNP > 125 pg/mL (BNP > 35 pg/mL);
- •Hemodynamic indicators (RHC) :
- •Mean pulmonary arterial pressure (mPAP) > 20 mmHg
- •Pulmonary capillary wedge pressure (PCWP) >15 mmHg
- •Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.
排除标准
- •Any of the following:
- •Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or
- •Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or
- •Untreated congenital heart disease; or
- •Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or
- •Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or
- •Anticipated to undergo ablation of atrial fibrillation within 6 months; or
- •Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or
- •Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD)
- •Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
- •Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
- •Anticipated to undergo any surgery within 6 months;
- •The cardiac index (CI) of RHC < 1.5L/min/m²;
- •Severe renal insufficiency (eGFR <30mL/min/1.73m² by MDRD formula);
- •Severe liver insufficiency (Child-Pugh classification C);
- •Platelet count < 50 × 10^9/L;
- •Life expectancy <1 year;
- •Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
- •Active infection requiring oral or intravenous antibiotics;
- •Body mass index (BMI) >40 kg/m²;
- •Pregnant or lactating women, or plan to pregnant in one year;
- •Participated in other clinical trials within 3 months prior to signing the informed consent;
- •Any other circumstances that investigators deem inappropriate to participate in this trial.
研究组 & 干预措施
Pulmonary Artery Denervation (PADN)
Patients in the PADN group will receive pulmonary artery denervation procedure.
干预措施: Pulmonary arterial denervation (Procedure)
Pulmonary Artery Denervation (PADN)
Patients in the PADN group will receive pulmonary artery denervation procedure.
干预措施: Guideline-directed medical therapy (GDMT) for heart failure (Drug)
Guideline-directed medical therapy (GDMT) for heart failure
Patients in the control group will take their baseline anti-heart failure medications at the original doses according to 2023 ESC Guidelines for heart failure, without any changes except when medically required. The anti-heart failure drugs treatment is consistent in both arms.
干预措施: Guideline-directed medical therapy (GDMT) for heart failure (Drug)
结局指标
主要结局
Clinical Worsening, defined as the occurrence of any of the followings:
时间窗: immediately after the randomization to the last enrolled subject having at least 6 months follow-up
1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure 2. Rehospitalization due to heart failure 3. 6MWD decreased by \> 10% or \> 30m compared with baseline 4. Referral for heart/heart-lung transplantation 5. All-cause death
次要结局
- Intravenous medication due to worsening of heart failure(1 month, 6 months, 1 year, 2 years, 3 years)
- Rehospitalization due to heart failure(1 month, 6 months, 1 year, 2 years, 3 years)
- N-terminal pro-B-type natriuretic peptide (NT-proBNP)(6 months)
- Changes in the Kansas City Cardiomyopathy Questionnaire(KCCQ) overall summary score from baseline(1 month, 6 months, 1 year, 2 years, 3 years)
- 6 minute walk distance(6MWD) difference from baseline(6 months, 1 year, 3 years)
- All-cause death(1 month, 6 months, 1 year, 2 years, 3 years)
- Heart/heart-lung transplantation(1 month, 6 months, 1 year, 2 years, 3 years)
- Parameters measured by transthoracic echocardiography(TTE)(6 months, 1 year, 3 years)
- Parameters measured by transthoracic echocardiography(TTE)(6 months, 1 year, and 3 years)