Smoking: a Risk Factor for Pulmonary Arterial Hypertension? (DACH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01484899
First received: November 28, 2011
Last updated: July 4, 2013
Last verified: July 2013

November 28, 2011
July 4, 2013
September 2011
October 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01484899 on ClinicalTrials.gov Archive Site
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Smoking: a Risk Factor for Pulmonary Arterial Hypertension?
Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland)

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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

All patients seen at participating DACH -PH centers who have PH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤15mmHg will be asked to participate upon written informed consent

Pulmonary Hypertension
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  • PAH
    Patients with pulmonary arterial hypertension (PH). PH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg
  • CTEPH
    Patients with chronic thromboembolic pulmonary hypertension. CTEPH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg.
  • Controll group
    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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • pulmonary artery pressure <25mmHg
  • pulmonary capillary occlusion pressure >15mmHg
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Switzerland
 
NCT01484899
DACH_1
No
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Silvia Ulrich, MD Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich
University of Zurich
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP