Smoking: a Risk Factor for Pulmonary Arterial Hypertension?

NCT ID: NCT01484899

Last Updated: 2013-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

CTEPH

Patients with chronic thromboembolic pulmonary hypertension. CTEPH defined as mean pulmonary artery pressure \>25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* pulmonary artery pressure \>25mmHg
* pulmonary capillary occlusion pressure ≤15mmHg

Exclusion Criteria

* pulmonary artery pressure \<25mmHg
* pulmonary capillary occlusion pressure \>15mmHg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Ulrich, MD

Role: PRINCIPAL_INVESTIGATOR

Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich

Locations

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University Hospital of Graz

Graz, , Austria

Site Status

University Hospital of Innsbruck

Innsbruck, , Austria

Site Status

University Hospital Dresden

Dresden, , Germany

Site Status

University of Greifswald

Greifswald, , Germany

Site Status

University Hospital of Heidelberg

Heidelberg, , Germany

Site Status

University hospital of Homburg

Homburg, , Germany

Site Status

University Hospital of Regensburg

Regensburg, , Germany

Site Status

University Hospital of Würzburg

Würzburg, , Germany

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Austria Germany Switzerland

Other Identifiers

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DACH_1

Identifier Type: -

Identifier Source: org_study_id

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