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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00949195
Other study ID # SZTE PULM-PAHP
Secondary ID ISRCTN11034505
Status Recruiting
Phase N/A
First received July 29, 2009
Last updated July 20, 2011
Start date September 2009
Est. completion date December 2011

Study information

Verified date October 2009
Source Szeged University
Contact Attila Somfay, MD, PhD
Phone +36-62-571-551
Email somfay@deszk.szote.u-szeged.hu
Is FDA regulated No
Health authority Hungary: National Institute of Pharmacy
Study type Observational

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2011
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years to 70 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Measure pulmonary artery pressure change during exercise
Semi-supine echocardiography test
Pulmonary pressure response during exercise
Semi-supine echocardiography test

Locations

Country Name City State
Hungary Department of Pulmonology, Szeged University Deszk Csongrad County

Sponsors (1)

Lead Sponsor Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary The degree of pulmonary artery pressure change during exercise? 2 months Yes
Secondary Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction? 2 months Yes
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