Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of Polymorphism on Pulmonary Pressure in Subjects With Pulmonary Hypertension of Different Cause

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sven Möbius-Winkler, University of Leipzig
ClinicalTrials.gov Identifier:
NCT00893178
First received: May 1, 2009
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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.


Condition
Congestive Heart Failure
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure [ Time Frame: Dec. 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of G308A TNF alpha polymorphism within the different groups [ Time Frame: Dec. 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

EDTA Blood, Serum


Estimated Enrollment: 600
Study Start Date: December 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

CHF elevated pulmonary hypertension

Criteria

Inclusion Criteria:

  • CHF with or without pulmonary hypertension or
  • patients with normal LVEF and pulmonary hypertension
  • right heart catheterization due to routine
  • informed consent

Exclusion Criteria:

  • no right heart catheterization
  • no informed consent
  • elevated pulmonary pressure due to valve diseases or congenital heart disease
  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: NCT00893178

Locations
Germany
Heart Center Leipzig- University Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Sven Moebius-Winkler, M.D.    0049-341-865 ext 1474    moes@medizin.uni-leipzig.de   
Contact: Volker Adams, PhD       adav@medizin.uni-leipzig.de   
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Sven Möbius-Winkler, M.D University Leipzig-Heart Center
  More Information

No publications provided

Responsible Party: Sven Möbius-Winkler, PI, University of Leipzig
ClinicalTrials.gov Identifier: NCT00893178     History of Changes
Other Study ID Numbers: SMW 03
Study First Received: May 1, 2009
Last Updated: September 2, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
eNOS Polymorphism
TNF alpha polymorphism
pulmonary pressure
polymorphism of vasoactive substances

Additional relevant MeSH terms:
Heart Failure
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014