Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy

Completed

• Conditions: Copd; Hypertension, Pulmonary; Hyperdistention

• Registration Number: NCT06613321
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).

The study will include all patients from the hospital, followed for pulmonary hypertension associated with COPD under vasodilator therapy between 2015 and 2021.

Detailed Description

The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).

The study will include all patients from the hospital, followed for PH associated with COPD under vasodilator therapy between 2015 and 2021.

It will evaluate patients' lung hyperinflation according to the RV/TLC ratio and their response to treatment.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-10-09
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Patients with COPD regardless of severity defined as a FEV1/FVC ratio less than 0.70 and the presence of a risk factor (smoke exposure with at least a 10 pack-year history, or professional exposition) diagnosed with PH according to ESC/ERS 2022 classification and in whom vasodilator therapy has been initiated

Exclusion Criteria

• other known concomitant lung disease (interstitial lung disease, cystic lung disease, mucoviscidosis...)
• thoracic pathology such as kyphoscoliosis
• pleural effusion (unless part of pulmonary veno-occlusive disease)
• a large tumor lung mass
• EFR missing or uninterpretable because difficult to perform
• initiation of calcium channel blockers
• surgical treatment in chronic thrombo-embolic pulmonary hypertension
• no follow-up evaluation (lost to follow-up or died before reassessment)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment	3 - 12 months	Response to treatment is defined as an improvement of at least 30 meters in the 6-minute walk test or one NYHA functional class at the first re-evaluation performed at least 3 months after the initiation of vasodilator therapy. These criteria will be compared according to the severity of chest distension.

Trial Locations

Locations (1)

CHU Nancy; 🇫🇷 Vandoeuvre-les-nancy, France