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

November 16, 2021 updated by: Sven Möbius-Winkler, University of Leipzig

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Heart Center Leipzig- University Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CHF elevated pulmonary hypertension

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure
Time Frame: Dec. 2010
Dec. 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of G308A TNF alpha polymorphism within the different groups
Time Frame: Dec. 2010
Dec. 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Heart Center Leipzig - University Hospital

Investigators

  • Principal Investigator: Sven Möbius-Winkler, M.D, University Leipzig-Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2007

Primary Completion (ACTUAL)

November 1, 2021

Study Completion (ACTUAL)

November 1, 2021

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (ESTIMATE)

May 5, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMW 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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