Smoking: a Risk Factor for Pulmonary Arterial Hypertension?

Pulmonary Hypertension Clinical Trial

— DACH  

Official title:

Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484899
• Other study ID #: DACH_1
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: July 4, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

Environmental factors may play a role in the genesis of pulmonary hypertension, especially in endothelial dysfunction. One widespread environmental factor associated with systemic endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact with other risk factors such as a genetic background and associated conditions. The existing studies which deal with this subject are only small single center case control studies providing less data. Therefore a large European multicenter study is necessary.

The investigators hypothesis are:

• a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to the unaffected general population.

• a history of tobacco smoke exposure is more prevalent in patients with PAH compared to CTEPH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pulmonary artery pressure >25mmHg

• pulmonary capillary occlusion pressure =15mmHg

Exclusion Criteria:

• pulmonary artery pressure <25mmHg

• pulmonary capillary occlusion pressure >15mmHg

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Austria	University Hospital of Graz	Graz
Austria	University Hospital of Innsbruck	Innsbruck
Germany	University Hospital Dresden	Dresden
Germany	University of Greifswald	Greifswald
Germany	University Hospital of Heidelberg	Heidelberg
Germany	University hospital of Homburg	Homburg
Germany	University Hospital of Regensburg	Regensburg
Germany	University Hospital of Würzburg	Würzburg
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Prevalence of Smoking history in patients with PAH compared to unaffected general population	Patients will be asked with a specific questionnaire concerning their tobacco smoke exposure and smoking history. Control-group: Data from Swiss health survey (SHS) 2007 (Gesundheitsbefragung Schweiz).	Assessment during outpatient consultation, an expected average of 1 day.	No