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
  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).


Enrollment: 500
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484899

Locations
Austria
University Hospital of Graz
Graz, Austria
University Hospital of Innsbruck
Innsbruck, Austria
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, Germany
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
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: July 4, 2013
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
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014