Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy

NCT ID: NCT06613321

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-03-25

Brief Summary

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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

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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.

Conditions

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Copd Hypertension, Pulmonary Hyperdistention

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Respiratory function tests before introduction of vasodilator therapy

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

Intervention Type DIAGNOSTIC_TEST

3 month follow up evaluation of response to treatment.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ari Chaouat, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Lorraine, Département de Pneumologie, CHRU NANCY

Locations

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CHU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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Farkouh C, Chaouat A, Guillaumot A, Baptista BR, Chabot F, Valentin S. Pulmonary hypertension in patients with chronic obstructive pulmonary disease: Impact of lung hyperinflation on the response to pulmonary hypertension treatment. Respir Med Res. 2025 May;87:101153. doi: 10.1016/j.resmer.2024.101153. Epub 2024 Dec 18.

Reference Type DERIVED
PMID: 39765128 (View on PubMed)

Other Identifiers

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2023PI014

Identifier Type: -

Identifier Source: org_study_id

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