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OpenTrials
Completed

NCT Number: NCT06613321

Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Respiratory function tests before introduction of vasodilator therapy

Diagnostic Test

Respiratory function tests before introduction of vasodilator therapy with evaluation of the RV/TLC ratio.

3 month follow up evaluation of response to treatment.

Diagnostic Test

Follow up of patients at least 3 months after introduction of vasodilator therapy to determine response to treatment or absence of response.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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