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Study of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA) (EVITA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02845518
Recruitment Status : Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Information provided by (Responsible Party):
ARI CHAOUAT, Central Hospital, Nancy, France

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18-75 years of age
  2. Incident cases of PAH,
  3. Prevalent cases of PAH diagnosed for less than 12 months when a re-evaluation is indicated including a right heart catheterization,
  4. Idiopathic, heritable PAH,
  5. PAH associated with appetite suppressant, systemic scleroderma, HIV infection or portal hypertension,
  6. PAH associated with repaired (> 1 year) congenital systemic-to-pulmonary shunt,
  7. Patients included in a biomedical trial to test a pharmaceutical treatment will be eligible provided that there is no incompatibility between the 2 studies.

Exclusion Criteria:

  1. Contraindication of cMRI and impossibility to undergo MRI,
  2. Patients not in normal sinus rhythm at baseline,
  3. Patients with pulmonary hypertension due to left heart disease,
  4. Patients with pulmonary hypertension due to lung diseases and/or hypoxemia,
  5. Chronic thromboembolic pulmonary hypertension,
  6. Patients treated with intravenous or subcutaneous prostanoids at baseline or have a formal indication of such treatment after the baseline evaluation,
  7. Comorbidities with a significant impact on the cardiovascular system,
  8. Pregnancy
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Responsible Party: ARI CHAOUAT, Ari Chaouat (Associate Professor), Central Hospital, Nancy, France Identifier: NCT02845518    
Other Study ID Numbers: PHRC-15-0210
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases