Comparing Effectiveness of Balloon Pulmonary Angioplasty Alone vs. Combined With Pulmonary Artery Denervation in Chronic Thromboembolic Pulmonary Hypertension Patients Receiving Standard Medical Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in mean Pulmonary Arterial Pressure (mPAP)
研究概览
简要总结
This clinical trial investigates new treatment approaches for chronic thromboembolic pulmonary hypertension (CTEPH), a condition affecting the lungs' blood vessels. CTEPH often develops after repeated blood clots in the lungs, leading to increased pressure and strain on the heart. The study aims to assess the effectiveness of combining two treatments, balloon pulmonary angioplasty (BPA) and pulmonary artery denervation (PADN), in reducing blood pressure in the lungs compared to the standard treatment. Additionally, the trial will explore the impact of these treatments on patients' quality of life. The hope is to improve outcomes and provide valuable insights into managing this challenging condition.
详细描述
This clinical trial focuses on advancing our understanding and treatment of chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH arises when blood clots in the lungs fail to fully dissolve, leading to the formation of fibrous masses that obstruct blood vessels, increase pulmonary blood pressure, and strain the heart's right ventricle.
The study's primary objective is to evaluate the combined use of two innovative treatments, Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), in comparison to the standard treatment for CTEPH. BPA involves using a balloon to open narrowed or blocked pulmonary arteries, while PADN is a novel therapy targeting nerve clusters near the main pulmonary artery to reduce blood pressure.
The trial also aims to assess the impact of these treatments on patients' quality of life and clinical improvement measured through the 6-Minute Walk Test Distance (6-MWTD) and the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaires.In addition to evaluating the combined efficacy of BPA and PADN compared to standard treatment, this clinical trial has a specific objective to customize the PADN intervention based on individual patient characteristics. The study aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN, considering the pulmonary artery size or diameter. This innovative approach seeks to tailor the intervention to the unique anatomical features of each patient, enhancing the precision and effectiveness of the treatment strategy.
The study design is a randomized parallel cohort study involving patients with CTEPH in phases 2/3. Patients are divided into two groups-intervention and control-and receive distinct treatment protocols. The intervention group undergoes a combination of BPA, PADN, and standard drug therapy, while the control group receives BPA, sham PADN intervention and standard drug therapy.
The BPA procedure involves accessing the pulmonary artery through the right femoral vein, measuring pressures, and selectively dilating stenosed or occluded branches. After the BPA procedure, PADN is performed by applying radiofrequency energy near the bifurcation of the main pulmonary artery.The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age 18 - 80 years.
- •Diagnosis of chronic thromboembolic heart disease.
- •Mean pulmonary arterial pressure (mPAP) >20 mmHg.
- •Pulmonary vascular resistance >3 Wood units.
- •Presence of organized thrombus masses.
- •World Health Organization (WHO) functional class II to IV.
排除标准
- •Proximal organized thrombotic masses not suitable for Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN).
- •WHO functional class I
- •Additionally, participants can be excluded from the trial under the following circumstances:
- •Withdrawal of consent at any time.
- •Failure to complete the treatment as per protocols.
- •Protocol violations.
结局指标
主要结局
Change in mean Pulmonary Arterial Pressure (mPAP)
时间窗: 3 months
Measure the change in mPAP from baseline to 3 months post-intervention to assess the effectiveness of the combined BPA and PADN therapy.
次要结局
- Quality of Life Assessment(3 months, and 1 year)
- Adverse Events(3 months, abd 1 year)
- Physical Functionality Assessment(3 months, and 1 year)
- Hemodynamic Response Assessment(1 year)
- Survival Rates(1 year)
研究者
Boris Dzudovic
Dr. Boris Dzudovic, MD, PhD, Teaching Assistant at Medical School, University of Defense
Military Medical Academy, Belgrade, Serbia