HOLLYWOOD: Hemodynamic Evaluation and Management of Pulmonary Hypertension With Inhaled Iloprost in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU)
研究概览
简要总结
Study Title: A Clinical Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension in Patients With Chronic Obstructive Pulmonary Disease (HOLLYWOOD)
The goal of this clinical study is to learn if the inhaled drug iloprost is effective and safe for treating pulmonary hypertension (PH) in adult patients who have severe or very severe Chronic Obstructive Pulmonary Disease (COPD).
The main questions it aims to answer are:
Does inhaled iloprost reduce the pressure and resistance in the lung's blood vessels (measured as Pulmonary Vascular Resistance - PVR)?
Does inhaled iloprost improve participants' ability to exercise, measured by how far they can walk in 6 minutes?
What are the side effects and medical problems that participants experience while taking inhaled iloprost?
Researchers will assess changes in participants' health by comparing measurements taken before they start taking inhaled iloprost to measurements taken after 12 weeks of treatment. There is no placebo group in this study.
Participants in this study will:
Use an inhaler to take iloprost 6 to 9 times every day for 12 weeks.
Visit the clinic for checkups at the beginning of the study and after the 12-week treatment period.
Undergo tests including an exercise capacity test (the 6-minute walk test) and heart pressure measurements (hemodynamic tests) before and after the treatment period.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older.
- •Established diagnosis of severe or very severe Chronic Obstructive Pulmonary Disease (COPD), corresponding to GOLD stage 3 or
- •Symptomatic Group 3 Pulmonary Hypertension (PH) confirmed by Right Heart Catheterization (RHC) with the following hemodynamic profile at rest:
- •Mean Pulmonary Artery Pressure (mPAP) > 35 mmHg.
- •Pulmonary Vascular Resistance (PVR) > 5 Wood Units (WU).
- •Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg.
- •Capable of providing written informed consent.
- •Exclusion criteria:
- •History of hypersensitivity to iloprost or other prostacyclin analogs.
- •Pregnancy or breastfeeding.
排除标准
- 未提供
研究组 & 干预措施
Inhaled Iloprost Treatment
Participants in this arm will receive inhaled iloprost for a 12-week period. The daily regimen consists of 6 to 9 inhalations, as tolerated. This is a single-group, pre-post study where clinical, exercise, and hemodynamic parameters are assessed at baseline (before treatment) and after 12 weeks to evaluate the efficacy and safety of the intervention.
干预措施: Iloprost is a synthetic molecule with pharmacological action (Drug)
结局指标
主要结局
Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU)
时间窗: Baseline and 12 weeks
Change in Pulmonary Vascular Resistance (PVR) from baseline to week 12. PVR is a measure of the resistance to blood flow in the pulmonary circulation. It will be measured in Wood Units (WU) and assessed via invasive hemodynamic monitoring (Right Heart Catheterization). A lower PVR indicates improved pulmonary hemodynamics.
次要结局
- Change from Baseline in 6-Minute Walk Distance (6MWD)(Baseline and 12 weeks)
- Change From Baseline in Dyspnea as Measured by the Transitional Dyspnea Index (TDI) Score(Baseline and 12 weeks)
- Change in Risk of Mortality Stratification(Baseline and 12 weeks)
- Change from Baseline in Mean Right Atrial Pressure (mRAP)(Baseline and 12 weeks)
- Change from Baseline in Mean Pulmonary Artery Pressure (mPAP)(Baseline and 12 weeks)
- Change from Baseline in Cardiac Index (CI)(Baseline and 12 weeks)
- Change from Baseline in Mixed Venous Oxygen Saturation (SvO2)(Baseline and 12 weeks)
研究者
Caio Júlio César dos Santos Fernandes
Collaborating Physician, Pulmonary Circulation Group, Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil
University of Sao Paulo General Hospital