NCT05996562招募中不适用
Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure: A Pilot Study
Pulnovo Medical (Wuxi) Co., Ltd.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月28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
- 30
- 试验地点
- 2
- 主要终点
- 6-minute walk distance (6MWD) difference
研究概览
简要总结
The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure.
Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18, ≤85 years;
- •PH must be confirmed by RHC, defined as:
- •Mean pulmonary arterial pressure (mPAP) >20mmHg, and;
- •Pulmonary capillary wedge pressure (PCWP) >15mmHg, and；
- •Pulmonary vascular resistance (PVR) > 2WU.
- •Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;
- •Clinically stable HF for at least 1 month, defined as:
- •No need of intravenous diuretics, inotropes or vasodilators, and
- •Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and
- •Resting heart rate (HR) ≥ 50 bpm and <100 bpm (>110 bpm in presence of atrial fibrillation) on the day of the procedure.
- •NYHA class II-IVa;
- •6MWD ≥ 100 m and ≤ 450 m;
- •NT-proBNP >125pg/mL (or BNP > 35pg/mL);
- •Understand and be willing to sign informed consent and be strictly willing to follow the protocol.
排除标准
- •Any of the following:
- •Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
- •Pericardial disease; or
- •Infiltrative or inflammatory myocardial disease; or
- •Valvular heart disease with stenosis or with severe regurgitation; or
- •Active endocarditis; or
- •Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
- •Congenital heart disease; or
- •Having 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 less than 6 months 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)
- •Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
- •Anticipated to undergo any surgery within the next 6 months;
- •Cardiac index (CI) measured by RHC < 1.5L/min/m2;
- •Severe renal insufficiency (eGFR < 30mL/min/1.73m2 by MDRD formula);
- •Severe liver insufficiency (Child-Pugh classification B-C);
- •Platelet count < 50 × 109/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;
- •Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;
- •Body mass index (BMI) > 40 kg/m²;
- •Pregnant or lactating women, or planning to be pregnant within one year;
- •Participation in other clinical trials within 3 months prior to signing the informed consent;
- •Any other circumstances that investigators deemed inappropriate to participate in this trial.
结局指标
主要结局
6-minute walk distance (6MWD) difference
时间窗: 6 months
The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.
次要结局
未报告次要终点
研究者
研究点 (2)
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