Non-invasive Assessment of Pulmonary Artery Pressure

NCT02223559 | Completed

• 1 other identifier: 25-593 ex 12/13
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.MRI is superior to echocardiography to non-invasively determine mean PAP in a broad collective of patients with PH of diverse ethology.
2. 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. 3.Novel right ventricular tissue Doppler parameters add substantially to "classical" echocardiography parameters to describe right ventricular function.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• mean pulmonary artery pressure

  at baseline

Secondary Outcomes (1)

• right ventricular function parameters

  at baseline

Study Arms (1)

right heart catheterization patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing right heart catheterization due to clinical reasons

Sponsors & Collaborators

• Medical University of Graz: lead
• National Bank of Austria: collaborator
• Ludwig Boltzmann Institute for Lung Vascular Research: collaborator

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples will be retrained

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Horst Olschewski, Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

AU (1)