Impact of Polymorphism on Pulmonary Pressure in Subjects... | NCT00893178

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

NCT00893178

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Nov 17, 2021Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Congestive Heart Failure
Pulmonary Hypertension

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007Actual

Primary Completion Date

Nov 2021Actual

Completion Date

Nov 2021Actual

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 4, 2009

First Posted Date

May 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2021

Last Update Posted Date

Nov 17, 2021Actual

Name	Class
Heart Center Leipzig - University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

CHF elevated pulmonary hypertension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven Möbius-Winkler, M.D	University Leipzig-Heart Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Leipzig- University Leipzig		Leipzig		04289	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided