Study of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA) (EVITA)
Pulmonary Arterial Hypertension
About this trial
This is an interventional diagnostic trial for Pulmonary Arterial Hypertension focused on measuring pulmonary hypertension, right ventricular function, hemodynamics, prognosis
Eligibility Criteria
Inclusion Criteria:
- 18-75 years of age,
- Incident cases of PAH, or Prevalent cases of PAH diagnosed for less than 12 months when a re-evaluation is indicated including a right heart catheterization with the intention of modifying the specific-PAH treatment: from mono to dual therapy or from bi to triple therapy (if the 3rd treatment planned is parenteral epoprostenol, the centre must be able to perform an MRI under epoprostenol IV),
- Idiopathic, heritable PAH, or PAH associated with medication or toxic, or systemic scleroderma, or HIV infection or portal hypertension, or PAH associated with repaired (> 1 year) congenital systemic-to-pulmonary shunt.
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:
- Contraindication of cardiac MRI and impossibility to undergo MRI,
- Patients not in normal sinus rhythm at baseline,
- Patients with PH due to left heart disease,
- Patients with PH due to lung diseases and/or hypoxemia,
- Chronic thromboembolic pulmonary hypertension,
- Comorbidities with a significant impact on the cardiovascular system such as valvulopathies, cardiomyopathy, severe hypertension despite appropriate treatment,
- Pregnancy,
- Patients under a measure of legal protection.
Sites / Locations
- Professor Ari CHAOUATRecruiting
Arms of the Study
Arm 1
Experimental
no arms
All patients included will undergo a cardiac Magnetic Resonance Imaging (cMRI) at the baseline visit (V1), at 3- or 6-month follow up visit (V2 or V3), at 24-month follow up visit and in case of clinical worsening during the first 24-month of follow up. All patients will complete a questionnaire on the acceptability and tolerability of cMRI and right heart catheterization at V1, V2 or V3 and V9, right heart catheterization being performed as a routine test in pulmonary arterial hypertension. Depending on patient agreement, 22 ml of peripheral venous blood will be taken at visits V1, V2 or V3 and V9. On one of these 3 visits a blood sample of 5 ml will be taken from the pulmonary artery during the right cardiac catheterization.