Longitudinal Outcomes of Patients With Group 3 Pulmonary Hypertension Treated With Iloprost

NCT07478094 | Completed

• 1 other identifier: SGP 28054
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This observational real-world study aims to evaluate the longitudinal clinical outcomes of adult patients with Group 3 pulmonary hypertension (PH), associated with chronic lung diseases such as interstitial lung disease, who are treated with inhaled iloprost in routine clinical practice. Treatment options for Group 3 PH remain limited, and the use of pulmonary vasodilators is controversial due to potential worsening of gas exchange. Inhaled iloprost may provide a more selective approach by targeting well-ventilated lung regions. However, real-world data on its use in this population are scarce. The primary objective of this study is to assess changes in clinical risk status over time using the COMPERA 2.0 four-stratum risk model. Secondary objectives include describing patient characteristics, treatment patterns, and the evolution of functional parameters and biomarkers, as well as documenting relevant clinical events such as hospitalizations, treatment escalation, and discontinuation. The study will retrospectively analyze data from approximately 50 adult patients with confirmed Group 3 PH who received inhaled iloprost as part of their routine care in a specialized pulmonary hypertension center. No additional patient contact or interventions will occur.

Conditions

Pulmonary Hypertension Due to Lung Diseases

Keywords

Group 3 Pulmonary Hypertension; Interstitial Lung Disease; Inhaled Iloprost; Observational Study

Outcome Measures

Primary Outcomes (1)

• Change in Risk Stratification According to the COMPERA 2.0 Four-Stratum Model

  Primary outcome is the longitudinal change in clinical risk category assessed using the COMPERA 2.0 four-stratum model (low, intermediate-low, intermediate-high, high risk). Risk status will be determined based on available clinical variables (World Health Organization functional class, 6-minute walk distance, and BNP or NT-proBNP levels, when available). The analysis will evaluate the proportion of patients who demonstrate improvement, stability, or worsening of risk category during follow-up compared with baseline (defined as initiation of inhaled iloprost).

  From baseline (initiation of inhaled iloprost) through available follow-up assessments during routine clinical care (follow-up of 3 to 6 months)

Secondary Outcomes (4)

• Change in World Health Organization (WHO) Functional Class

  From baseline (initiation of inhaled iloprost) through available follow-up assessments during routine clinical care (follow-up of 3 to 6 months)

• Change in 6-Minute Walk Distance (6MWD)

  From baseline (initiation of inhaled iloprost) through available follow-up assessments during routine clinical care (follow-up of 3 to 6 months)

• Change in BNP or NT-proBNP Levels

  From baseline (initiation of inhaled iloprost) through available follow-up assessments during routine clinical care (follow-up of 3 to 6 months)

• Clinical Events During Follow-up

  From baseline (initiation of inhaled iloprost) through available follow-up assessments during routine clinical care (follow-up of 3 to 6 months)

Study Arms (1)

Group 3 Pulmonary Hypertension Treated With Inhaled Iloprost

Adults (≥18 years) with group 3 pulmonary hypertension (PH due to chronic lung disease and/or hypoxia) followed at a specialized pulmonary circulation outpatient clinic who received inhaled iloprost during routine clinical care. Group 3 PH was confirmed by right heart catheterization according to current hemodynamic criteria and in the presence of documented underlying lung disease (e.g., interstitial lung disease or chronic obstructive pulmonary disease).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with pulmonary hypertension due to chronic lung disease and/or hypoxia (group 3 pulmonary hypertension) receiving care at a specialized pulmonary circulation outpatient clinic. The study population includes patients with underlying interstitial lung disease or chronic obstructive pulmonary disease who were treated with inhaled iloprost as part of routine clinical practice. The cohort represents a real-world population followed longitudinally using data available from medical records, without additional study-specific procedures or patient contact.

You may qualify if:

• Age ≥18 years
• Diagnosis of group 3 pulmonary hypertension confirmed by right heart catheterization, defined as mean pulmonary artery pressure \>20 mmHg, pulmonary artery wedge pressure ≤15 mmHg, and pulmonary vascular resistance \>2 Wood units
• Presence of documented underlying chronic lung disease (e.g., interstitial lung disease confirmed by high-resolution computed tomography with restrictive pattern on pulmonary function testing, or chronic obstructive pulmonary disease)
• Use of inhaled iloprost for a minimum of 3 months, documented in medical records
• Availability of baseline clinical data (at initiation of inhaled iloprost) and at least one follow-up assessment

You may not qualify if:

• Pulmonary hypertension from other clinical groups (Groups 1, 2, 4, or 5) as the predominant diagnosis
• Insufficient clinical information in medical records to allow characterization or longitudinal assessment

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caio Fernandes

  Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist, PhD

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 17, 2026
• Study Start: May 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

BR (1)