Non-invasive Assessment of Pulmonary Artery Pressure

Non-invasive Assessment of Pulmonary Artery Pressure and Right Ventricular Function in Patients With Pulmonary Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing right heart catheterization due to clinical reasons

Description

Inclusion Criteria: patients undergoing right heart catheterization due to clinical reasons -

Exclusion Criteria: patients not eligible for MRI, patients not agreeing with investigation

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
right heart catheterization patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean pulmonary artery pressure	at baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
right ventricular function parameters	at baseline

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: National Bank of Austria; Ludwig Boltzmann Institute for Lung Vascular Research
• Investigators: Principal Investigator: Horst Olschewski, Prof., Medical University of Graz

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 25-593 ex 12/13