Pulmonary Arterial Pressure Response During Exercise

• Conditions: Flow-mediated Vasodilatation (FMD); Healthy Subjects; High Sensitive C-reactive Protein (hsCRP); Semi-supine Echo (SSE); COPD Patients
• Interventions: Other: Measure pulmonary artery pressure change during exercise; Other: Pulmonary pressure response during exercise

• Registration Number: NCT00949195
• Lead Sponsor: Szeged University

Brief Summary

Background:

The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.

Methods:

Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.

Primary endpoint:

The degree of pulmonary artery systolic pressure change during exercise?

Secondary endpoint:

1. The degree of right ventricular function change during exercise?

2. Is endothel dysfunction manifested with pulmonary artery pressure rise?

3. What is the correlation between the systemic inflammatory marker hsCRP and the degree of pulmonary artery pressure rise?

Detailed Description

Background: The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise by semi-supine echocardiography and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.

Methods: Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. All of the subjects perform complete lung function with body pletysmography and diffusion capacity measurement. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.

Study Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Study Start: 2009-09
• Status Verified: 2009-10
• Primary Completion: 2009-12
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• COPD patients (age between 45 and 70)
• with moderate to severe obstruction (FEV1<60%pred) and
• healthy subjects (age between 45 and 70, (FEV1>80%pred, FEV1/FVC>70%

Exclusion Criteria

• Not in the age range
• Different FEV1 value
• Severe comorbidities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Measure pulmonary artery pressure change during exercise	Age-matched healthy subjects performed the same test also.
COPD patients	Measure pulmonary artery pressure change during exercise	COPD patients with severe obstruction performed the tests.
COPD patients	Pulmonary pressure response during exercise	COPD patients with severe obstruction performed the tests.
Healthy subjects	Pulmonary pressure response during exercise	Age-matched healthy subjects performed the same test also.

Primary Outcome Measures

Name	Time	Method
The degree of pulmonary artery pressure change during exercise?	2 months

Secondary Outcome Measures

Name	Time	Method
Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?	2 months

Trial Locations

Locations (1)

Department of Pulmonology, Szeged University; 🇭🇺 Deszk, Csongrad County, Hungary