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Simultaneously right heart catheterization and echocardiography in patients with pulmonary arterial hypertension to validate the non-invasive deformation-area loop


- candidate number28425
- NTR NumberNTR6974
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jan-2018
- Secondary IDs2017-3460 CMO regio Arnhem-Nijmegen
- Public TitleSimultaneously right heart catheterization and echocardiography in patients with pulmonary arterial hypertension to validate the non-invasive deformation-area loop
- Scientific TitleSimultaneously right heart catheterization and echocardiography in patients with pulmonary arterial hypertension to validate the non-invasive deformation-area loop
- ACRONYMPressure-volume curve vs. deformation-area loop
- hypothesisObjective: The overall aim of this project is to correlate the characteristic changes of the deformation-area loop to the properties of the pressure-volume curve. We hypothesize that the systolic slope of the deformation-area loop relates to the end-systolic pressure-volume relationship of the pressure volume curve.
- Healt Condition(s) or Problem(s) studiedPulmonary arterial hypertension
- Inclusion criteria- strong suspicion of PAH, WHO group 1, confirmed during right hearth catheterization.
- Over 18 years of age
- voluntary
- Exclusion criteria- cardiovascular diseases, other than PAH
- diabetes mellitus
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-jan-2018
- planned closingdate31-dec-2019
- Target number of participants20
- InterventionsTo create the pressure-volume changes we will use a balloon-catheter to partially obstruct the venous return in the Vena Cava inferior.
- Primary outcome- The relation between the systolic slope of the deformation-area loop and the end-systolic pressure-volume relationship of the pressure volume curve.
- The relation between the slope of the diastolic part of the deformation-area loop during passive filling and the end-diastolic pressure-volume relationship of the pressure volume curve.
- Secondary outcomeOther correlation between the characteristics of the deformation-area loop and the pressure-volume curve.
- Timepointsna
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. Hugo Hulshof
- CONTACT for SCIENTIFIC QUERIESDr. Dick H.J. Thijssen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summaryRecent technical developments allow monitoring of strain and area using echocardiography. Using this information enables the production of an deformation-area loop. In this study we will investigate the relationship between the non-invasive deformation-area loop and the pressure-volume curve, during different loading conditions of the right ventricle
- Main changes (audit trail)
- RECORD10-jan-2018 - 2-feb-2018


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