Hemodynamic Effects of Inhaled Iloprost in PH-COPD (HOLLYWOOD)

Browse trials for

• Pulmonary Disease, Chronic Obstructive 4,131
• Hypertension, Pulmonary 1,105

Keywords

• Pulmonary Hypertension
• COPD
• Hemodynamics
• Prostacyclin Analog
• iloprost
• Chronic Obstructive Pulmonary Disease (COPD)
• Group 3 Pulmonary Hypertension
• PH-COPD

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 15 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Experimental
  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.

  Drug: Iloprost is a synthetic molecule with pharmacological action

Interventions

• DrugIloprost is a synthetic molecule with pharmacological action

  Ventavis® is the commercial brand name for inhaled iloprost in Brazil.

Primary outcomes

1. Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU)

   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.

   Time frame: Baseline and 12 weeks

Secondary outcomes

1. Change from Baseline in 6-Minute Walk Distance (6MWD)

   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.

   Time frame: Baseline and 12 weeks

2. Change From Baseline in Dyspnea as Measured by the Transitional Dyspnea Index (TDI) Score

   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.

   Time frame: Baseline and 12 weeks

3. Change in Risk of Mortality Stratification

   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.

   Time frame: Baseline and 12 weeks

4. Change from Baseline in Mean Right Atrial Pressure (mRAP)

   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.

   Time frame: Baseline and 12 weeks

5. Change from Baseline in Mean Pulmonary Artery Pressure (mPAP)

   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.

   Time frame: Baseline and 12 weeks

6. Change from Baseline in Cardiac Index (CI)

   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.

   Time frame: Baseline and 12 weeks

7. Change from Baseline in Mixed Venous Oxygen Saturation (SvO2)

   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.

   Time frame: Baseline and 12 weeks

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in this article, including clinical, exercise, and hemodynamic data, will be made available to qualified researchers upon reasonable request. A data sharing proposal should be submitted to the corresponding author. The proposal will be reviewed by the study investigators for scientific merit and feasibility. To gain access, data requestors will need to sign a data access agreement and commit to using the data in a manner consistent with the original informed consent provided by the participants.