|- candidate number||22205|
|- NTR Number||NTR5230|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mei-2015|
|- Secondary IDs||2015-1832 CMO regio Arnhem-Nijmegen|
|- Public Title||Prognostic value of a Non-invasive surrogate for right ventricular pressure-volume loops|
|- Scientific Title||Prognostic value of a Non-invasive surrogate for right ventricular pressure-volume loops|
|- ACRONYM||Prognostic value of the deformation-area curve in PAH patients|
|- hypothesis||Objective: The overall aim of this project is to asses the prognostic value of the characteristics of an echocardiographic surrogate pressure-volume loop on mortality and morbidity due to PAH.
|- Healt Condition(s) or Problem(s) studied||Pulmonary arterial hypertension|
|- Inclusion criteria||1. Patients diagnosed with PAH |
2. NICE-group 1, NYHA classification II-IV
3. Presence of an echocardiographic assessment
4. ≥ 18 years of age;
5. Mentally able/allowed to give informed consent.
|- Exclusion criteria||1. Absence of an echocardiographic assessment|
2. Different classification of PAH
3. Not willing to participate in this research
4. Absence of contact information
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2015|
|- planned closingdate||1-dec-2018|
|- Target number of participants||250|
|- Interventions||A questionnaire regarding physical health, hospital or general practitioner visits and change in treatment will be send annually.|
|- Primary outcome||1. Mortality|
In case of morbidity secondary cardiovascular diseases, newly prescribed medication and surgery events will be monitored.
|- Secondary outcome||n.a.|
|- Timepoints||Echocardiographic assessments after diagnosis of PAH will be used as baseline time point to analyze the characteristics of the surrogate pressure-volume loop. Registration of morbidity and mortality events will be used as time points to determine the prognostic value of these characteristics.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc. Hugo Hulshof|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Dick H.J. Thijssen|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary||Pulmonary arterial hypertension (PAH) is a progressive disease with a mean 4-year survival rate of 50-60%. Due to an increase in pulmonary arterial resistance the right ventricle needs to adapt to the increased workload. Often this results in dilatation of the right ventricle en eventually in right sided heart failure. Nowadays right heart catheterization is used tot diagnose PAH, by measuring the pressure and volume changes over time a pressure-volume loop is created. This loop provides functional information of the right ventricle. Unfortunately right heart catheterization is an invasive procedure associated with certain risks.
A recently developed analysis technique based on echocardiographic assessments provides information about the functional information of the ventricles. This data can be used to reconstruct surrogate pressure-volume loop. Continues registration of this loop can be used to provide information of the right ventricle in a non-invasive way.
A combination of these analyzed surrogate pressure volume loops with data from patient files and municipal population register will be used in an attempt to predict mortality and morbidity in patients with pulmonary arterial hypertension.
|- Main changes (audit trail)|
|- RECORD||18-mei-2015 - 11-aug-2015|