COPD, Pulmnary Hypertension, Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Conditions
Keywords
Pulmonary Hypertension, COPD, Hemodynamics, Prostacyclin Analog, iloprost, Chronic Obstructive Pulmonary Disease (COPD), Group 3 Pulmonary Hypertension, PH-COPD
Brief summary
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.
Interventions
DRUGIloprost is a synthetic molecule with pharmacological action
Ventavis® is the commercial brand name for inhaled iloprost in Brazil.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 40 years or older. * Established diagnosis of severe or very severe Chronic Obstructive Pulmonary Disease (COPD), corresponding to GOLD stage 3 or 4. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Dyspnea as Measured by the Transitional Dyspnea Index (TDI) Score | Baseline and 12 weeks | The Transitional Dyspnea Index (TDI) measures changes in dyspnea from a baseline state. The baseline state is established using the Baseline Dyspnea Index (BDI). The TDI score is derived from three categories: functional impairment, magnitude of task, and magnitude of effort. The total score ranges from -9 (major deterioration) to +9 (major improvement). A higher positive score indicates a greater improvement in dyspnea. |
| Change in Risk of Mortality Stratification | Baseline and 12 weeks | Change in the patient's risk of mortality as assessed by the COMPERA 2.0 risk assessment model. This model stratifies patients into low, intermediate, or high risk based on a combination of clinical and hemodynamic variables. |
| Change from Baseline in Mean Right Atrial Pressure (mRAP) | Baseline and 12 weeks | Change in mean right atrial pressure (mRAP) from baseline to week 12. mRAP reflects right ventricular preload. It will be measured in millimeters of mercury (mmHg) via Right Heart Catheterization. |
| Change from Baseline in 6-Minute Walk Distance (6MWD) | Baseline and 12 weeks | Change in the distance in meteres a participant can walk on a hard, flat surface in 6 minutes. The 6MWD is a measure of exercise capacity. |
| Change from Baseline in Cardiac Index (CI) | Baseline and 12 weeks | Change in Cardiac Index (CI) from baseline to week 12. CI is a measure of cardiac performance relative to body size. It will be measured in liters per minute per square meter (L/min/m²) via Right Heart Catheterization. An increase indicates improved cardiac function. |
| Change from Baseline in Mixed Venous Oxygen Saturation (SvO2) | Baseline and 12 weeks | Change in mixed venous oxygen saturation (SvO2) from baseline to week 12. SvO2 reflects the balance between systemic oxygen delivery and consumption. It will be measured as a percentage (%) via Right Heart Catheterization. |
| Change from Baseline in Mean Pulmonary Artery Pressure (mPAP) | Baseline and 12 weeks | Change in mean pulmonary artery pressure (mPAP) from baseline to week 12. mPAP is a key hemodynamic parameter for monitoring pulmonary hypertension. It will be measured in millimeters of mercury (mmHg) via Right Heart Catheterization. |
Contacts
Primary ContactCaio JC Fernandes, PhD
Outcome results
None listed