Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Response to treatment
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Response to treatment
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported