Clinical trial NCT00949195: Pulmonary Arterial Pressure Response During Exercise
Official title: Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Patients
Healthy Subjects
Semi-supine Echo (SSE)
Flow-mediated Vasodilatation (FMD)
High Sensitive C-reactive Protein (hsCRP)
Keywords: COPD
healthy patients
PAP
CPX
SSE
hsCRP
FMD
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients (age between 45 and 70) with moderate to severe obstruction (FEV1\<60%) and healthy subjects (age between 45 and 70)

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.

Eligibility criteria: 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

Primary outcomes:
measure: The degree of pulmonary artery pressure change during exercise?
timeFrame: 2 months
Secondary outcomes:
measure: Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?
timeFrame: 2 months
Other outcomes:
Locations:
city: Deszk
country: Hungary
facility: Department of Pulmonology, Szeged University
state: Csongrad County
Study officials:
affiliation: Department of Pulmonology, Szeged University
name: Attila Somfay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varga J, Palinkas A, Lajko I, Horvath I, Boda K, Somfay A. Pulmonary Arterial Pressure Response During Exercise in COPD: A Correlation with C-Reactive Protein (hsCRP). Open Respir Med J. 2016 Jan 29;10:1-11. doi: 10.2174/1874306401610010001. eCollection 2016.