跳至主要内容
临床试验/NCT03755726
NCT03755726招募中不适用

A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

Centre Hospitalier de PAU37 个研究点 分布在 2 个国家目标入组 1,200 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
37
主要终点
prognosis

研究概览

简要总结

This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

详细描述

Malignant hypertension is the most severe form of high blood pressure, fatal if left untreated. It has not disappeared, with an increasing incidence. Patients with the disease, mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of cardiovascular and renal events at 4 years). Despite these facts, scientific research on the subject remains limited. The definitions and diagnostic criteria have not changed since 1929, and the therapeutic recommendations remain empirical.

This first prospective and multicentric registry will increase and modernize the knowledge of the disease. From these data, diagnostic and therapeutic recommendations based on solid scientific evidence could be developed.

The investigators want to first recruit 500 patients and define their prognosis at 5 years. The impact of the patient's phenotype, type and number of target organs affected will be studied.

A modern definition, adapted to these results, could be proposed. The epidemiology of the disease, the care pathways, the target organ disorders and the management carried out in the centers will be described in detail.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Malignant hypertension according to the classic definition (Severe hypertension, above 180/110 associated with severe hypertensive retinopathy)
  • Severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure

排除标准

  • Age < 18 years old
  • Patients who cannot freely give their consent, or patients who refuse to participate

结局指标

主要结局

prognosis

时间窗: 5 years

5-year prognosis for patients with malignant hypertension

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Romain Boulestreau

Principal Investigator

Centre Hospitalier de PAU

研究点 (37)

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