Study of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA) (EVITA)
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|ClinicalTrials.gov Identifier: NCT02845518|
Recruitment Status : Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary vascular resistance leading to right ventricular (RV) failure and eventually to death. The therapeutic strategy has become complex and needs to perform recurring follow up evaluations including a right heart catheterization (RHC).
Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right ventricular (RV) volumes and important prognostic predictors such as cardiac index, stroke volume (SV) and right ventricular ejection fraction (RVEF).
The main objective is to assess the hemodynamic diagnosis performances (sensibility and specificity) at baseline and at follow up visits of cMRI to detect an unfavorable hemodynamic status in comparison with the results of the RHC (current guidelines).
The primary endpoint is: sensitivity and specificity of cMRI for the diagnosis of an unfavorable status defined by the current RHC criteria (with 95% confidence interval).
The secondary objectives are: to identify clinical and hemodynamic variables independently contributing to prognosis, to quantify complications due to cMRI and to RHC and to compare acceptability and tolerability of cMRI over RHC for the patient.
PAH patients will be recruited in 18 centers of the French network of severe pulmonary hypertension in a prospective cohort study.
180 subjects will be enrolled in the study: that size will give the study 90% power to find significant at the 5%-level.
If the primary endpoint were reached, since first, strategies and procedures planed in this project are consistent with those currently used in routine and second, inclusion criteria are not limited to a sub-population of PAH patients, positive results could allow to broadly extending our findings. Therefore, it will be possible to decrease the number of RHC, an invasive and cumbersome procedure without altering the prognosis. Moreover all clinical procedures would be performed in outpatient clinics and thereby would reduce the cost to assess the severity of the disease. Current recommendations for evaluation of severity and follow-up being mainly derived from consensus of opinion of the experts, positive results will also improve the level evidence of severity assessment of PAH patients.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Procedure: Cardiac magnetic resonance imaging||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EValuation of Cardiac Magnetic Resonance Imaging in Follow up assessmenT of Patients With Pulmonary Arterial Hypertension (EVITA)|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: cMRI AND RHC
Cardiac Magnetic Resonance Imaging (cMRI) and Right Heart Catheterization (RHC) (the latter being recommended in the current guidelines) in all patients at the baseline visit, at 4-6 months of follow up, at 24 months of follow up and in case of clinical worsening from the baseline visit to 24-month of follow up
Procedure: Cardiac magnetic resonance imaging
RV contouring and indexed aortic flow measurement from cMRI will be performed locally with the dedicated software used in clinical practice by the physicians of each centre. Cardiac index and RVEF will be derived from these measures. MRI interpretation will be performed blind with respect of clinical and RHC data.
Right atrial pressure, pulmonary artery pressures and cardiac index will be measured with RHC as currently recommended, therefore performing RHC will not be considered as an intervention but as a routine practice
- Unfavorable hemodynamic status (categorical variable) [ Time Frame: All visits will be pooled as one time point (unfavorable hemodynamic status from baseline to 24-month of follow up) ]
Unfavorable hemodynamic status in RHC is defined by a cardiac index (CI)< 2.5 l/min/m² or a right atrial pressure > 8 mm Hg (currently accepted criteria).
Unfavorable hemodynamic status in cMRI is defined by a CI < 2.5 l/min/m² or (right ventricular ejection fraction) RVEF < 35% or an absolute decrease of RVEF of 10% or more.
Sensitivity, specificity and 95 % confidence intervals of cMRI to determine an unfavorable hemodynamic status compared to the RHC criteria as the gold standard will be calculated from all couples of measures of cMRI-RHC performed during the study
- Morbimortality events and comparison of physical/psychological distress due to cMRI and RHC [ Time Frame: From baseline to the end of the study. The end of the study is defined by the 24-month visit of the last patient included. ]
Morbimortality events will be defined as one of the first following
- 1 .Death from any cause
- 2 .Lung transplantation
- 3.Atrial septostomy
- 4.Worsening of PAH defined by all three following criteria: a decrease in the 6-minute walk distance of at least 15 % from baseline, a worsening of PAH symptoms and an unscheduled hospitalization due to PAH
- 5.Unsatisfactory status from non-hemodynamic parameters
Physical and psychological distress due to cMRI and RHC will be measured with questionnaires.