Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy
Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre-les-nancy, France, 54500
- Chu Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with increased lung distension
Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) above the median value of all included patients.
|
Respiratory function tests before introduction of vasodilator therapy with evaluation of the RV/TLC ratio.
Follow up of patients at least 3 months after introduction of vasodilator therapy to determine response to treatment or absence of response.
|
|
Patients without increased distension disorder
Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) below the median value of all included patients.
|
Respiratory function tests before introduction of vasodilator therapy with evaluation of the RV/TLC ratio.
Follow up of patients at least 3 months after introduction of vasodilator therapy to determine response to treatment or absence of response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 - 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ari Chaouat, MD PhD, Université de Lorraine, Département de Pneumologie, CHRU NANCY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023PI014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.