Pulmonary Arterial Pressure Response During Exercise

Healthy Subjects Clinical Trial

— PAPCOPDHS  

Official title:

Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects

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

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

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