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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 : Recruiting
First Posted : July 27, 2016
Last Update Posted : April 30, 2021
Sponsor:
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 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 and 4) to constitute biological collection of blood samples to determine diagnostic and prognostic PAH biomarkers.

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.


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Procedure: Cardiac magnetic resonance imaging (cMRI) 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)
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : February 16, 2024
Estimated Study Completion Date : February 16, 2024


Arm Intervention/treatment
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.

Procedure: Cardiac magnetic resonance imaging (cMRI)

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 Lickert 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.

Other Names:
  • Questionnaire
  • Blood samples




Primary Outcome Measures :
  1. Performance of Cardiac Magnetic Resonance Imaging to detect an unfavorable hemodynamic state compared to the results of the Right Heart Catheterization [ Time Frame: All visits will be pooled as one time point (unfavorable hemodynamic status from baseline to 24-month of follow up) ]
    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.


Secondary Outcome Measures :
  1. 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. [ 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. ]
    The predictive value of the first occurrence of morbimortality events in 2 different analyses derived from RHC criteria and from cMRI criteria.

  2. 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. [ 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. ]
    To assess the link between the first morbi-mortality event and the following factors (New York Heart Association (NYHA) functional class, 6-minute walk distance, plasma level of B-type natriuretic peptide (BNP)/N-terminal(NT)-proBNP, and continuous hemodynamic variables from cMRI, RHC and echocardiography), identifying clinical and hemodynamic variables independently contributing to prognosis in univariate analyses.

  3. 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. [ Time Frame: From baseline visit to 24 month visit. ]
    To assess the link between the first morbi-mortality event and the following factors (New York Heart Association (NYHA) functional class, 6-minute walk distance, plasma level of B-type natriuretic peptide (BNP)/N-terminal(NT)-proBNP, and continuous hemodynamic variables from cMRI, RHC and echocardiography), identifying clinical and hemodynamic variables independently contributing to prognosis in multivariate analyses.

  4. Secondary objective 4.a: Complications due to cMRI and to RHC [ Time Frame: From baseline visit to 24 month visit. ]
    This will be mostly a descriptive analysis. The overall frequency of reported adverse events and severe adverse events will be compared between groups using the Chi-Square test (or Fisher's exact test where requested).

  5. Secondary objective 4.b: Complications due to cMRI and to RHC [ Time Frame: From baseline visit to 24 month visit. ]
    This will be mostly a descriptive analysis. The overall frequency of reported adverse events and severe adverse events will be compared between groups to account for the paired nature of the data, a McNemar test will be performed.

  6. Secondary objective 5: The magnitude of better tolerability of cMRI over RHC for the patient [ Time Frame: From baseline visit to 24 month visit. ]

    Physical and psychological distress due to cMRI and RHC will be measured with questionnaires.

    The comparison of the Likert-type scales of the questionnaires will be carried out using the Chi-Square test.


  7. Secondary objective 6: Create a biobank for diagnosis and prognosis purposes [ Time Frame: From baseline visit to 24 month visit. ]
    Blood samples to obtain DNA from circulating blood cells and plasma



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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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845518


Contacts
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Contact: CHAOUAT ARI, MD, PHD 0033 3 83 15 37 08 a.chaouat@chru-nancy.fr
Contact: CHERIFI ABOUBAKER, Ms 0033 3 83 15 70 84 a.cherifi@chru-nancy.fr

Locations
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France
Professor Ari CHAOUAT Recruiting
Vandœuvre-lès-Nancy, France, 54511
Contact: CHAOUAT ARI, MD, PHD    0033 3 83 15 37 08    a.chaouat@chru-nancy.fr   
Contact: CHERIFI Aboubaker, Ms    0033 3 83 15 70 84    a.cherifi@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: CHAOUAT ARI, MD, PHD Central Hospital, Nancy, France
  Study Documents (Full-Text)

Documents provided by ARI CHAOUAT, Central Hospital, Nancy, France:
Statistical Analysis Plan  [PDF] December 15, 2020

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Responsible Party: ARI CHAOUAT, Ari Chaouat (Associate Professor), Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02845518    
Other Study ID Numbers: PHRC-15-0210
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARI CHAOUAT, Central Hospital, Nancy, France:
pulmonary hypertension
right ventricular function
hemodynamics
prognosis
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases