Smoking: a Risk Factor for Pulmonary Arterial Hypertension? (DACH)
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|ClinicalTrials.gov Identifier: NCT01484899|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : July 8, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Observational Model:||Case Control|
|Official Title:||Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
Patients with pulmonary arterial hypertension (PH). PH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg
Patients with chronic thromboembolic pulmonary hypertension. CTEPH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg.
Data from 16322 (10336 females) participants of the Swiss health survey (SHS) 2007 will serve as control. The SHS was performed in 2007, a representative sample of 30000 Swiss citizens were asked to participate, 66% answered per telephone to detailed health question.
- Difference in Prevalence of Smoking history in patients with PAH compared to unaffected general population [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484899
|University Hospital of Graz|
|University Hospital of Innsbruck|
|University Hospital Dresden|
|University of Greifswald|
|University Hospital of Heidelberg|
|University hospital of Homburg|
|University Hospital of Regensburg|
|University Hospital of Würzburg|
|University Hospital Zurich|
|Zurich, Switzerland, 8091|
|Principal Investigator:||Silvia Ulrich, MD||Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich|