Smoking: a Risk Factor for Pulmonary Arterial Hypertension?

Completed

• Conditions: Pulmonary Hypertension

• Registration Number: NCT01484899
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• pulmonary artery pressure >25mmHg
• pulmonary capillary occlusion pressure ≤15mmHg

Exclusion Criteria

• pulmonary artery pressure <25mmHg
• pulmonary capillary occlusion pressure >15mmHg

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in Prevalence of Smoking history in patients with PAH compared to unaffected general population	Assessment during outpatient consultation, an expected average of 1 day.	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).

Trial Locations

Locations (9)

University Hospital of Innsbruck; 🇦🇹 Innsbruck, Austria

University of Greifswald; 🇩🇪 Greifswald, Germany

University Hospital of Graz; 🇦🇹 Graz, Austria

University Hospital Dresden; 🇩🇪 Dresden, Germany

University Hospital of Heidelberg; 🇩🇪 Heidelberg, Germany

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

University hospital of Homburg; 🇩🇪 Homburg, Germany

University Hospital of Regensburg; 🇩🇪 Regensburg, Germany

University Hospital of Würzburg; 🇩🇪 Würzburg, Germany