Non-invasive Assessment of Pulmonary Artery Pressure

NCT ID: NCT02223559

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-06-30

Brief Summary

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The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular function stand in the focus of the diagnosis and clinical management of pulmonary hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure PAP and to provide hemodynamic information on right ventricular function. However, due to its invasive nature, RHC is not optimal for screening and for close monitoring of the disease. Therefore, the development of non-invasive methods providing reliable PAP measurements and right ventricular functional parameters would be of major benefit.

Today, the most often used comprehensive non-invasive method for these purposes is echocardiography. However, the method has limitations; in many cases PAP is significantly under- or overestimated - especially in subjects with co-existing pulmonary diseases. Regarding right ventricular function, although novel echocardiography parameters appear to be promising, they have not yet been evaluated in all forms of PH.

Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is considered to be as gold standard for the non-invasive assessment of right ventricular function. In addition, our group showed that with a special approach ("vortex method"), MRI enables the determination of PAP with physiologic accuracy, but the method has not yet been validated systematically in different forms of PH.

All patients undergoing right heart catheterization in our clinic are candidates for the study. Excluded will be patients not eligible for MRI or declining to take part in the study. MRI and Echocardiography will be performed within two weeks of the RHC.

Hypothesis:

1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad collective of patients with PH of diverse ethology.
2. MRI derived right ventricular functional parameters correlate better to invasive measurements and to established prognostic parameters than echocardiography derived right ventricular functional parameters.
3. Novel right ventricular tissue Doppler parameters add substantially to "classical" echocardiography parameters to describe right ventricular function.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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right heart catheterization patients

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Bank of Austria

OTHER_GOV

Sponsor Role collaborator

Ludwig Boltzmann Institute for Lung Vascular Research

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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25-593 ex 12/13

Identifier Type: -

Identifier Source: org_study_id

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