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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614900
Other study ID # PreKPH-08
Secondary ID jnr 2007-0206
Status Completed
Phase N/A
First received January 31, 2008
Last updated September 17, 2012
Start date March 2008
Est. completion date March 2011

Study information

Verified date September 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Observational

Clinical Trial Summary

The prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. The aim of this study is to determine the prevalence of an increased pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung function test results and blood tests can predict an increased pulmonary blood pressure, and explore whether COPD patients with a high pulmonary blood pressure have more symptoms that their co-patients.


Description:

The prevalence of pulmonary hypertension in patients with chronic obstructive pulmonary disease (COPD) is unclear. The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of COPD, but the patients are not currently diagnosed or treated for pulmonary hypertension. The aim of this study is to determine the prevalence of pulmonary hypertension in 200 patients with COPD and explore whether it worsens functional capacity and symptoms. Furthermore we will look into whether blood gas values, NT-proBNP, CRP and lung function test result can predict which patients are at risk of having pulmonary hypertension.

Methods: All patients will be screened by echocardiography. Those with signs of pulmonary hypertension will be admitted to right heart catheterization for direct measurements of pulmonary haemodynamics.

All patients will perform a 6 minutes walk test and spirometry. Blood levels of NT-proBNP and CRP will be measured. Life quality by the St. George Questionnaire and contacts to the health care system is also assessed. Differences in these parameters are analyzed among patients with no, moderate or severe pulmonary hypertension.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of COPD

- Prior admittance to hospital with exacerbation in COPD

- Informed consent

Exclusion Criteria:

- Exacerbation in COPD less than 6 weeks before examination

Study Design

Time Perspective: Cross-Sectional


Locations

Country Name City State
Denmark Department of pulmonary diseases, Aarhus Sygehus Århus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

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