Study Results
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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UNKNOWN
80 participants
OBSERVATIONAL
2009-09-30
2011-12-31
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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COPD patients
COPD patients with severe obstruction performed the tests.
Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Pulmonary pressure response during exercise
Semi-supine echocardiography test
Healthy subjects
Age-matched healthy subjects performed the same test also.
Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Pulmonary pressure response during exercise
Semi-supine echocardiography test
Interventions
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Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Pulmonary pressure response during exercise
Semi-supine echocardiography test
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with moderate to severe obstruction (FEV1\<60%pred) and
* healthy subjects (age between 45 and 70, (FEV1\>80%pred, FEV1/FVC\>70%
Exclusion Criteria
* Different FEV1 value
* Severe comorbidities
45 Years
70 Years
ALL
Yes
Sponsors
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Szeged University
OTHER
Responsible Party
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Department of Pulmonology, Szeged University
Principal Investigators
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Attila Somfay, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Pulmonology, Szeged University
Locations
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Department of Pulmonology, Szeged University
Deszk, Csongrád megye, Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ISRCTN11034505
Identifier Type: -
Identifier Source: secondary_id
SZTE PULM-PAHP
Identifier Type: -
Identifier Source: org_study_id
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