Mathematical Models Derived Indices for the Selection and Planning of a Specific Optimal Treatment to the Patient in Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Prediction from the model computer remodeling reverse
研究概览
简要总结
Heart failure is a growing throughout pathology in Europe. It is a public health issue and an economic issue. The management to be effective needs to be early but specific. Generic treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years and has demonstrated its effectiveness, come s'ajouter solutions specific, technically complex and expensive to implement. Because of the potential risk to the patient and their cost to the company, these new techniques need to be adapted to each case. The passage of a generic simple treatment for everyone in the single treatment tailored to each patient requires decision support tools for the clinician. These tools or decision trees are developed using mathematical and statistical models fed by all patient data (imaging, biology physiology ...) before and after implementation of treatment. Predictive response models of a treatment applied to a particular pathology can thus be generated.
It is this type of models applied in systolic heart failure complicated by mitral regurgitation and / or cardiac synchronization that will be generated in this project from 150 patients included in 3 European clinical studies (London, Brussels, Caen). In Caen we will include 30 patients in this single-center study
详细描述
Heart failure (HF) is a clinical problem increasingly common throughout Europe, partly because of the aging population and increasing numbers of patients now survive after myocardial infarction [1, 2] . The IC is a progressive disease and when patients require hospitalization, long-term prognosis is poor [3]. The treatment of IC is focused on improving the work of the failing heart via the use of specific drugs, if necessary by cardiovascular interventions correcting structural lesions (mitral regurgitation) or correcting a disorganized contraction (therapy resynchronization). However, the IC is a disease complex with multiple factors pathophysiological interdependent making difficult treatment choices optimal or of a combination therapeutic optimal.
The technologies HPV predictive, such as tools for processing data, statistical models and simulations biophysical that incorporate these factors pathophysiological have tremendous potential to help improve our understanding of the response to treatment in the context of the IC. In particular, they have the potential to improve the selection of patients for cardiovascular interventions such as cardiac resynchronization therapy and / or that an intervention on the mitral valve [4].
Projects recent - European (HPV or Human physiological virtual) and national - have developed a large number of these technologies, but n'ont not been fully released into the environment clinic to help care for patients IC.
The objective of VP2HF project is to develop and validate in clinical settings computer modeling platform to integrate non-invasive clinical and imaging evidence acquired in patients with heart failure ( IC) for two reasons:
- Identify for each patient, the likely response to different therapeutic interventions with all clinical data processed by a decision support system.
- Optimize responses or interventions selected for each patient to maximize treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given informed consent for participation in the study.
- •Male or female, aged 18 years
- •Heart failure stage II -IV NYHA .
- •Be awaiting a response to cardiac resynchronization therapy (CRT ) or replacement / repair of the mitral valve (MVR / r )
- •Affiliated to social security scheme
- •Francophone
排除标准
- •Age <18 years
- •Major Adult guardianship
- •Pregnancy , lactation, or desire to start a pregnancy during the study period ( for women)
- •Contraindications to MRI
- •Continuous Treatment or continuous infusion with an inotropic agent for heart failure.
- •Recent myocardial infarction ( <1 month) requiring revascularization
- •unbalanced severe hypertension ( BP> 160/110 mmHg)
- •Significant hepatic impairment
- •Any other significant disease or condition, which in the opinion of the investigator , may create a risk for the participant because of its participation in the study , or affect the results of the study, or to affect the patient's ability to participate in the study .
结局指标
主要结局
Prediction from the model computer remodeling reverse
时间窗: 6 month after intervention
Prediction from the model computer remodeling reverse as defined by reduced LVESV 15 % (on ultrasound or MRI) 6 months after the intervention (CRT or VCR / r ) .
次要结局
- MLHFQ Questionnaire(6 month after intervention)
- 6 minute walk test ( 6MWT )(6 month after intervention)
- NT-proBNP(6 month after intervention)
- VO2 max(6 month after intervention)
- non-invasive measurement of central blood pressure(6 month after intervention)