Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Decipher the mechanisms responsible for the transition from severe to malignant hypertension
研究概览
简要总结
The HAMA bank is an initiative aimed at collecting, preparing, and storing biological samples from patients treated for malignant hypertension and included in the HAMA cohort. Conducted under CRB (ISO20387) conditions, this biobank serves as an essential resource for understanding the disease's pathophysiology, as well as for identifying novel biomarkers and therapeutic targets
详细描述
Malignant hypertension (MH) is an acute and severe form of hypertension that can lead to rapid target organ damage and potentially be fatal within months if not treated. Despite the severity, MH manifests in various phenotypes, suggesting multiple underlying pathophysiological pathways. The HAMA bank aims to address this by collecting biological samples at two distinct time-points:
For " Pre-existing Patients " in the HAMA cohort: A one-time collection focused on genetic analysis. A full sample (equivalent to sample 1 below) may be collected in option.
For Newly Diagnosed Patients (Incident Patients): Sample 1 "Acute Phase": Collected between Day 0 and Day 7 post-admission to any HAMA recruiting centers. This will be used for initial multi-omics analysis. Sample 2 "Chronic Phase": Collected between the 1st and 6th months during a follow-up visit at the investigating center.
These samples will be cross-referenced with clinical and biological data from the HAMA cohort. The cohort follow-up schedule is: 1, 3, 6, 12 months after MH diagnosis and annually for a total of 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •patients included in the HAMA cohort with the following critera :
- •Malignant hypertension according to the classic definition (Severe hypertension associated with severe hypertensive retinopathy)
- •Severe hypertension associated with acute target organ damage due to high blood pressure
排除标准
- •Refusal to participate to the substudy " HAMA bank "
- •patient on chronic dialysis
结局指标
主要结局
Decipher the mechanisms responsible for the transition from severe to malignant hypertension
时间窗: At inclusion and 6 month
Compare the multiomic signature of patients admitted for malignant hypertension, between MHT acute crisis (admission) and resolution (6 month later). Transcriptomic, proteomic and metabolomic evolution between these 2 time points and focus on genetic background in relevant system, like angiogenic, vasoactif system, complement system and inflammasome will be described.
次要结局
- Focus on the role of complement system in MHT crisis(At inclusion and 6 month)
- Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisis(At inclusion)