Pulmonary Arterial Pressure Response During Exercise (PAPCOPDHS)

July 20, 2011 updated by: Szeged University

Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Csongrad County
      • Deszk, Csongrad County, Hungary, 6772
        • Recruiting
        • Department of Pulmonology, Szeged University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Attila Somfay, MD, PhD
        • Sub-Investigator:
          • Janos Varga, MD
        • Sub-Investigator:
          • Imre Lajko, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD patients
COPD patients with severe obstruction performed the tests.
Other: Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Other Names:
  • lung function, CPX, HsCRP
Other: Pulmonary pressure response during exercise
Semi-supine echocardiography test
Other Names:
  • 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 Names:
  • lung function, CPX, HsCRP
Other: Pulmonary pressure response during exercise
Semi-supine echocardiography test
Other Names:
  • Complete lung function, CPX, HsCRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The degree of pulmonary artery pressure change during exercise?
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Investigators

  • Principal Investigator: Attila Somfay, MD, PhD, Department of Pulmonology, Szeged University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZTE PULM-PAHP
  • ISRCTN11034505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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