Smoking: a Risk Factor for Pulmonary Arterial Hypertension? (DACH)
This study is currently recruiting participants.
Verified November 2011 by University of Zurich
Sponsor:
University of Zurich
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01484899
First received: November 28, 2011
Last updated: November 30, 2011
Last verified: November 2011
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Purpose
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 |
|---|
|
Pulmonary Hypertension |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland) |
Resource links provided by NLM:
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- 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).
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2011 |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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
Criteria
Inclusion Criteria:
- pulmonary artery pressure >25mmHg
- pulmonary capillary occlusion pressure ≤15mmHg
Exclusion Criteria:
- pulmonary artery pressure <25mmHg
- pulmonary capillary occlusion pressure >15mmHg
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484899
Contacts
| Contact: Silvia Ulrich, MD | 0041442554362 | silvia.ulrich@usz.ch |
Locations
| Austria | |
| University Hospital of Graz | Recruiting |
| Graz, Austria | |
| Contact: Gabor Kovacs, M.D. | |
| University Hospital of Innsbruck | Recruiting |
| Innsbruck, Austria | |
| Contact: Cris Kähler, M.D. | |
| Germany | |
| University Hospital Dresden | Recruiting |
| Dresden, Germany | |
| Contact: Michael Halank, M.D. michael.halank@uniklinikum-dresden.de | |
| University of Greifswald | Recruiting |
| Greifswald, Germany | |
| Contact: Tom Bollmann | |
| University Hospital of Heidelberg | Recruiting |
| Heidelberg, Germany | |
| Contact: Ekkehard Grüning | |
| University hospital of Homburg | Recruiting |
| Homburg, Germany | |
| Contact: Heinrike Wilkens | |
| University Hospital of Regensburg | Recruiting |
| Regensburg, Germany | |
| Contact: Tobias Lange, M.D. | |
| University Hospital of Würzburg | Recruiting |
| Würzburg, Germany | |
| Contact: Mattias Held, M.D. | |
| Switzerland | |
| University Hospital Zurich | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Silvia Ulrich, MD 0041442554362 silvia.ulrich@usz.ch | |
Sponsors and Collaborators
University of Zurich
Investigators
| Principal Investigator: | Silvia Ulrich, MD | Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01484899 History of Changes |
| Other Study ID Numbers: | DACH_1 |
| Study First Received: | November 28, 2011 |
| Last Updated: | November 30, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University of Zurich:
|
Pulmonary arterial Hypertension Chronic thromboembolic pulmonary hypertension smoking |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Smoking Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Habits |
ClinicalTrials.gov processed this record on June 18, 2013