EValuation of Cardiac Magnetic Resonance Imaging in Follow up assessmenT of Patients With Pulmonary Arterial Hypertension (EVITA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Performance of Cardiac Magnetic Resonance Imaging to detect an unfavorable hemodynamic state compared to the results of the Right Heart Catheterization
研究概览
简要总结
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.
详细描述
Evaluation of cardiac magnetic resonance Imaging in follow up assessmenT of patients with pulmonary Arterial hypertension (EVITA) is a prospective cohort study of cMRI in PAH.
EVITA is a multicenter biomedical research study. All the investigation centers belong to the French network of severe pulmonary hypertension.
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 right heart catheterizations (RHC). Although, RHC performed in experience centers has low mortality and low morbidity, repeated invasive pulmonary hemodynamic measurements are burdensome and still presents some risk of complications. Once the diagnosis of PAH is established, follow up evaluation devoted to modifying specific therapy relies mainly on RV function parameters. Thus, echocardiography and cardiac magnetic resonance imaging (cMRI) meet many of the criteria of ideal monitoring tools.
Echocardiography is safe, inexpensive and widely available. However, this test has several limitations. Firstly, due to the complexity of the right ventricle chamber, the measurement of RV volumes is difficult. Secondly, criteria are numerous and for quantitative measurements different thresholds are applied without accepted definition. Thirdly, operator dependency could make it difficult to obtain reproducible images.
Cardiac MRI has the advantage to accurately assess RV volumes and important prognostic predictors such as cardiac index, stroke volume (SV) and right ventricular ejection fraction (RVEF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cardiac magnetic resonance imaging (cMRI) (Procedure)
结局指标
主要结局
Performance of Cardiac Magnetic Resonance Imaging to detect an unfavorable hemodynamic state compared to the results of the Right Heart Catheterization
时间窗: 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.
次要结局
- 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 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.)
- Secondary objective 6: Create a biobank for diagnosis and prognosis purposes(From baseline visit to 24 month visit.)
- Secondary objective 9: prognostic value to predict the first occurrence of morbimortality events of cMRI variables (including indexed stroke volume) after taking into account NYHA, 6-minute walk test distance and BNP or NT-proBNP after 4 months treatment(From baseline visit to 24 month visit.)
- Secondary objective 5: The magnitude of better tolerability of cMRI over RHC for the patient(From baseline visit to 24 month visit.)
- Secondary objective 7: measurements of indexed stroke volume performed by RHC and by cMRI(From baseline visit to 24 month visit.)
- Secondary objective 8: prognostic value to predict an unfavourable hemodynamic status of cMRI variables (including indexed stroke volume) after taking into account NYHA, 6-minute walk test distance and BNP or NT-proBNP after 4 months treatment(From baseline visit to 24 month visit.)
- 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.)
研究者
ARI CHAOUAT
Ari Chaouat (Associate Professor)
Central Hospital, Nancy, France