Congestive Heart FailureNCT00893178
Impact of Polymorphism on Pulmonary Pressure in Subjects With Pulmonary Hypertension of Different Cause
An observational study of Congestive Heart Failure and Pulmonary Hypertension, run by University of Leipzig at 1 site in Germany.
Trial summary
Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Pulmonary Hypertension
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Nov 2021
- 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: CHF elevated pulmonary hypertension
Who may be able to join
- CHF with or without pulmonary hypertension or
- patients with normal LVEF and pulmonary hypertension
- right heart catheterization due to routine
- informed consent
Who cannot join
- no right heart catheterization
- no informed consent
- elevated pulmonary pressure due to valve diseases or congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Different Genetic Polymorphism on the Pulmonary Pressure in Patients With Pulmonary Hypertension of Different Cause With Special Focus on Patients With Chronic Heart Failure
Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected.
Especially patients with chronic heart failure can develope PH. The reasons therefore are lacking.
The researchers investigate different polymorphism and the influence of these on pulmonary artery pressure (measured invasively) in patients with congestive heart failure (CHF) and patients with primary pulmonary hypertension.
Read the detailed description
The study consists of 3 arms-patients with CHF and PH, patients with CHF without PH and patients without CHF and PH.
The PH measurement is due to routine catheterization, thereafter we measure different vasoactive polymorphism.
- Conditions
- Congestive Heart Failure, Pulmonary Hypertension
- Keywords
- eNOS Polymorphism, TNF alpha polymorphism, pulmonary pressure, polymorphism of vasoactive substances
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary
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 |
|---|---|---|
| CHF with elevated PAP | CHF patients (LVEF > 35%) with elevated mean pulmonary pressure( > 20 mmHg ) measured by pa catheter | |
| CHF patient without elevated PAP | CHF patients (LVEF > 35%) with normal mean pulmonary pressure | |
| Normal EF with elevated PAP | Patients with normal LVEF < 60% with elevated mean pulmonary pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure
Measured: Dec. 2010
Secondary outcomes (1)
Rate of G308A TNF alpha polymorphism within the different groups
Measured: Dec. 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startDec 2007
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Responsible party
- Principal investigator, Sven Möbius-Winkler, University of Leipzig
- Investigators
- Sven Möbius-Winkler, M.D, Principal investigator, University Leipzig-Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893178
- Sponsor's protocol ID
- SMW 03
- Status last verified
- Nov 2021
- First submitted
- 1 May 2009
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Genetic Polymorphism on the Pulmonary Pressure in Patients With Pulmonary Hypertension of Different Cause With Special Focus on Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00893178
- Acronym / sponsor ID
- SMW 03
- Conditions
- Congestive Heart Failure, Pulmonary Hypertension
- Keywords
- eNOS Polymorphism, TNF alpha polymorphism, pulmonary pressure, polymorphism of vasoactive substances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Study start
- Dec 2007 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 5 May 2009 (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.
Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected.
Especially patients with chronic heart failure can develope PH. The reasons therefore are lacking.
The researchers investigate different polymorphism and the influence of these on pulmonary artery pressure (measured invasively) in patients with congestive heart failure (CHF) and patients with primary pulmonary hypertension.
Detailed description
The study consists of 3 arms-patients with CHF and PH, patients with CHF without PH and patients without CHF and PH.
The PH measurement is due to routine catheterization, thereafter we measure different vasoactive polymorphism.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF with elevated PAP | – | –CHF patients (LVEF > 35%) with elevated mean pulmonary pressure( > 20 mmHg ) measured by pa catheter |
| CHF patient without elevated PAP | – | –CHF patients (LVEF > 35%) with normal mean pulmonary pressure |
| Normal EF with elevated PAP | – | –Patients with normal LVEF < 60% with elevated mean pulmonary pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CHF elevated pulmonary hypertension
Key inclusion criteria (4 listed)
- CHF with or without pulmonary hypertension or
- patients with normal LVEF and pulmonary hypertension
- right heart catheterization due to routine
- informed consent
Key exclusion criteria (3 listed)
- no right heart catheterization
- no informed consent
- elevated pulmonary pressure due to valve diseases or congenital heart disease
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
Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure
Time frame: Dec. 2010
1 secondary outcome
Rate of G308A TNF alpha polymorphism within the different groups
Time frame: Dec. 2010
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 17 Nov 2021.
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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.
Sven Möbius-Winkler, M.D principal investigator
University Leipzig-Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Pulmonary Hypertension, run by University of Leipzig at 1 site in Germany.
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 4 inclusion and 3 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 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure (time frame: Dec. 2010). 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 17 Nov 2021.