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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00893178
Other study ID # SMW 03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2007
Est. completion date November 2021

Study information

Verified date November 2021
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Germany Heart Center Leipzig- University Leipzig Leipzig

Sponsors (2)

Lead Sponsor Collaborator
University of Leipzig Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure Dec. 2010
Secondary Rate of G308A TNF alpha polymorphism within the different groups Dec. 2010
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