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

NCT02845518 | Recruiting DMC

• 1 other identifier: PHRC-15-0210
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary vascular resistance leading to right ventricular failure and eventually to death. The therapeutic strategy has become complex and needs to perform recurring follow up evaluations including right heart catheterizations (RHC). Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right ventricular volumes and important prognostic predictors such as cardiac index, stroke volume and right ventricular ejection fraction. The main objective of EVITA is to assess the hemodynamic diagnosis performances at baseline and at follow up visits of cMRI in comparison with the results of the RHC (current guidelines) to detect an unfavorable hemodynamic status. 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 1) to identify clinical and hemodynamic variables independently contributing to prognosis, 2) to describe complications due to cMRI and to RHC, 3) to compare acceptability and tolerability of cMRI over RHC for the patient, 4) to constitute biological collection of blood samples to determine diagnostic and prognostic PAH biomarkers, 5) To compare the measurements of indexed stroke volume performed by RHC and by cMRI, 6) To evaluate the prognostic value to predict an unfavourable hemodynamic status of cMRI variables (including indexed stroke volume) after taking into account NYHA functional class, 6-minute walk test distance and BNP or NT-proBNP after 4 months of PAH treatment and 7) To evaluate the prognostic value to predict the first occurrence of morbimortality events of cMRI variables (including indexed stroke volume) after taking into account NYHA functional class, 6-minute walk test distance and BNP or NT-proBNP after 4 months of PAH treatment. PAH patients will be recruited in 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 achieved, 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 extend 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. According to secondary objectives we expect to better predict morbimortality events with cMRI compared to RHC.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary hypertension; right ventricular function; hemodynamics; prognosis

Outcome Measures

Primary Outcomes (1)

• Performance of Cardiac Magnetic Resonance Imaging to detect an unfavorable hemodynamic state compared to the results of the Right Heart Catheterization

  Cardiac Magnetic Resonance Imaging CI \< 2.5 l/min/m2 or a right ventricle ejection fraction (RVEF) \< 35% or an absolute decrease of 10% of RVEF at a follow-up evaluation (for the second and third time-point) compared to cardiac index\< 2.5 l/min/m2 or right atrial pressure \> or = to 8 mm Hg measured with Right Heart Catheterization.

  All visits will be pooled as one time point (unfavorable hemodynamic status from baseline to 24-month of follow up)

Secondary Outcomes (10)

• Secondary objective 1: The predictive value of the first occurrence of morbimortality events in 2 different analyses derived from RHC criteria and from cMRI criteria.

  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.

• Secondary objective 2: The link between first morbimortality events occurrence and covariates, identifying variables independently contributing to prognosis in univariate analyses, to build a multiparameter prognostic score.

  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.

• Secondary objective 3: The link between first morbimortality events occurrence and covariates, identifying variables independently contributing to prognosis in multivariate analyses, to build a multiparameter prognostic score.

  From baseline visit to 24 month visit.

• Secondary objective 4.a: Complications due to cMRI and to RHC

  From baseline visit to 24 month visit.

• Secondary objective 4.b: Complications due to cMRI and to RHC

  From baseline visit to 24 month visit.

Study Arms (1)

no arms

EXPERIMENTAL

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.

Procedure: Cardiac magnetic resonance imaging (cMRI)

Interventions

Cardiac magnetic resonance imaging (cMRI) PROCEDURE

Right ventricular 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. A self-administered questionnaire made up of 2 Likert scales will be given to all patients on visits V1, V2 or V3 and V9. To constitute a biobank for diagnosis and prognosis purposes blood samples will be taken at visits V1, V2 or V3 and V9.

Also known as: Questionnaire, Blood samples

no arms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Professor Ari CHAOUAT

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• CHAOUAT ARI, MD, PHD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHAOUAT ARI, MD, PHD

CONTACT

0033 3 83 15 37 08; a.chaouat@chru-nancy.fr

CHERIFI ABOUBAKER, Ms

CONTACT

0033 3 83 15 70 84; a.cherifi@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ari Chaouat (Associate Professor)

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 27, 2016
• Study Start: February 16, 2017
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)