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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).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06613321
Enrollment
47
Registered
2024-09-25
Start date
2023-08-01
Completion date
2024-03-25
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd, Hyperdistention, Hypertension, Pulmonary

Keywords

copd, pulmonary distension, lung distension disorders, pulmonary hypertension, vasodilator therapy

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.

Interventions

DIAGNOSTIC_TESTRespiratory function tests before introduction of vasodilator therapy

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

DIAGNOSTIC_TEST3 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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Response to treatment3 - 12 monthsResponse 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026