NCT01484899

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

November 28, 2011

Last Update Submit

July 4, 2013

Conditions

Pulmonary Hypertension

Keywords

Pulmonary arterial HypertensionChronic thromboembolic pulmonary hypertensionsmoking

Outcome Measures

Primary Outcomes (1)

  • Difference in Prevalence of Smoking history in patients with PAH compared to unaffected general population

    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).

    Assessment during outpatient consultation, an expected average of 1 day.

Study Arms (3)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • pulmonary artery pressure \<25mmHg
  • pulmonary capillary occlusion pressure \>15mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital of Graz

Graz, Austria

Location

University Hospital of Innsbruck

Innsbruck, Austria

Location

University Hospital Dresden

Dresden, Germany

Location

University of Greifswald

Greifswald, Germany

Location

University Hospital of Heidelberg

Heidelberg, Germany

Location

University hospital of Homburg

Homburg, Germany

Location

University Hospital of Regensburg

Regensburg, Germany

Location

University Hospital of Würzburg

Würzburg, Germany

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial HypertensionSmoking

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Silvia Ulrich, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 2, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

DE(6)AU(2)CH(1)