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Pulmonary Arterial Pressure Response During Exercise (PAPCOPDHS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Szeged University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Szeged University
ClinicalTrials.gov Identifier:
NCT00949195
First received: July 29, 2009
Last updated: July 20, 2011
Last verified: October 2009
History of Changes
  Purpose

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?

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Szeged University:

Primary Outcome Measures:
  • The degree of pulmonary artery pressure change during exercise? [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction? [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Blood sample is taken to analyse the systemic inflammatory marker (hsCRP) level from serum. We measure the samples and than we don't store it.


Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD patients
COPD patients with severe obstruction performed the tests.
 Other: Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Other Name: lung function, CPX, HsCRP
Other: Pulmonary pressure response during exercise
Semi-supine echocardiography test
Other Name: Complete lung function, CPX, HsCRP
Healthy subjects
Age-matched healthy subjects performed the same test also.
 Other: Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Other Name: lung function, CPX, HsCRP
Other: Pulmonary pressure response during exercise
Semi-supine echocardiography test
Other Name: Complete lung function, CPX, HsCRP

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949195

Contacts
Contact: Attila Somfay, MD, PhD +36-62-571-551 somfay@deszk.szote.u-szeged.hu
Contact: Janos Varga, MD +36-62-571-527, +36209204235 janosvargaster@gmail.com

Locations
Hungary
Department of Pulmonology, Szeged University Recruiting
Deszk, Csongrad County, Hungary, 6772
Contact: Attila Somfay, MD, PhD     +36-62-571-552     somfay@deszk.szote.u-szeged.hu    
Contact: Janos Varga, MD     +36-62-571-527, +36209204235     janosvargaster@gmail.com    
Principal Investigator: Attila Somfay, MD, PhD            
Sub-Investigator: Janos Varga, MD            
Sub-Investigator: Imre Lajko, MD            
Sponsors and Collaborators
Szeged University
Investigators
Principal Investigator: Attila Somfay, MD, PhD Department of Pulmonology, Szeged University
  More Information

No publications provided

Responsible Party: Attila Somfay, MD, PhD; Department Leader, Department of Pulmonology, Szeged University
ClinicalTrials.gov Identifier: NCT00949195     History of Changes
Other Study ID Numbers: SZTE PULM-PAHP, ISRCTN11034505
Study First Received: July 29, 2009
Last Updated: July 20, 2011
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Szeged University:
COPD
healthy patients
PAP
CPX
 SSE
hsCRP
FMD

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013