Pulmonary HypertensionDACHNCT01484899
Smoking: a Risk Factor for Pulmonary Arterial Hypertension?
An observational study of Pulmonary Hypertension, run by University of Zurich at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 500 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Sep 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- pulmonary artery pressure >25mmHg
- pulmonary capillary occlusion pressure ≤15mmHg
Who cannot join
- pulmonary artery pressure <25mmHg
- pulmonary capillary occlusion pressure >15mmHg
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany6 sites
University Hospital Dresden
Dresden
University of Greifswald
Greifswald
University Hospital of Heidelberg
Heidelberg
University hospital of Homburg
Homburg
University Hospital of Regensburg
Regensburg
University Hospital of Würzburg
Würzburg
Austria2 sites
University Hospital of Graz
Graz
University Hospital of Innsbruck
Innsbruck
About this study
Official title: 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.
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial Hypertension, Chronic thromboembolic pulmonary hypertension, smoking
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessment during outpatient consultation, an expected average of 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, MD, Principal investigator, Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484899
- Sponsor's protocol ID
- DACH_1
- Acronym
- DACH
- Status last verified
- Jul 2013
- First submitted
- 28 Nov 2011
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland)
- ClinicalTrials.gov ID
- NCT01484899
- Acronym / sponsor ID
- DACH / DACH_1
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial Hypertension, Chronic thromboembolic pulmonary hypertension, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- pulmonary artery pressure >25mmHg
- pulmonary capillary occlusion pressure ≤15mmHg
Key exclusion criteria (2 listed)
- pulmonary artery pressure <25mmHg
- pulmonary capillary occlusion pressure >15mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Ulrich, MD principal investigator
Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by University of Zurich at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.