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Pulmonary Arterial Pressure Response During Exercise (PAPCOPDHS)

U

University of Szeged (SZTE)

Status

Unknown

Conditions

High Sensitive C-reactive Protein (hsCRP)
Semi-supine Echo (SSE)
Flow-mediated Vasodilatation (FMD)
Healthy Subjects
COPD Patients

Treatments

Other: Measure pulmonary artery pressure change during exercise
Other: Pulmonary pressure response during exercise

Study type

Observational

Funder types

Other

Identifiers

NCT00949195
ISRCTN11034505
SZTE PULM-PAHP

Details and patient eligibility

About

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?

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Attila Somfay, MD, PhD; Janos Varga, MD

Data sourced from clinicaltrials.gov

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