Using cardiac MRI to assess patients with pulmonary arterial hypertension

EValuation of Cardiac Magnetic Resonance Imaging in Follow up assessmenT of Patients With Pulmonary Arterial Hypertension (EVITA)

This study is testing if a special heart scan can better monitor patients with pulmonary arterial hypertension compared to the usual testing method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Central Hospital, Nancy, France (other)
• Locations: 1 site (Vandœuvre-lès-Nancy)
• Trial ID: NCT02845518 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of cardiac magnetic resonance imaging (cMRI) in monitoring patients with pulmonary arterial hypertension (PAH). It aims to compare the diagnostic performance of cMRI against traditional right heart catheterization (RHC) methods to identify unfavorable hemodynamic statuses. The study involves a multicenter approach within the French network of severe pulmonary hypertension, focusing on patients who require follow-up evaluations for treatment modifications. By assessing right ventricular function and other prognostic indicators, the study seeks to improve the management of PAH.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed or recently diagnosed pulmonary arterial hypertension requiring follow-up evaluations.

Not a fit: Patients who cannot undergo cardiac MRI or are not in normal sinus rhythm at baseline may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive alternative for monitoring PAH, reducing the need for invasive procedures.

How similar studies have performed: Previous studies have shown promise in using cMRI for cardiac assessments, suggesting potential for success in this approach.

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 (pulmonary hypertension) 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.

Where this trial is running

Vandœuvre-lès-Nancy

• Professor Ari CHAOUAT — Vandœuvre-lès-Nancy, France (RECRUITING)

Study contacts

• Principal investigator: CHAOUAT ARI, MD, PHD — Central Hospital, Nancy, France
• Study coordinator: CHAOUAT ARI, MD, PHD

Conditions: Pulmonary Arterial Hypertension, pulmonary hypertension, right ventricular function, hemodynamics, prognosis