NCT01716819已完成不适用
Role of the Renin Angiotensin Aldosterone System and Remodeling of the Matrix Cardiac Extra Cellular in the Mechanisms of Transition to Heart Failure in Abdominal Obesity: Prospective Longitudinal Study R2C2 II
Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- cardiac extracellular matrix remodelling
研究概览
简要总结
R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to confirm the hypothesis that RAAS is associated with an early remodelling and implicated in the transition to cardiac failure in abdominal obesity.
详细描述
Follow up of abdominal obesity patients from the R2C2 cohort study.
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
- 43 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a former member of R2C2 study, abdominal obese group.
- •Having signed the informed consent (refusing to participate to the genetic study is not an
排除标准
- •being affiliated to health insurance scheme.
- •Inclusion Criteria of R2C2 study:
- •Men and women aged between 40 and 65 year's old
- •Caucasian
- •Born or living in France for at least 10 years
- •Presenting an abdominal obesity defined by a waist circumference >94 cm in men and ≥ 80 cm in women, associated or not with untreated hypertension or hypertension treated for less than one year
- •Having signed the informed consent
- •Exclusion Criteria:
- •Subjects unable to understand the information letter
- •Subjects under supervision or guardianship
- •pregnant or lactating woman
- •A contraindication to perform MRI is not an exclusion criteria.
结局指标
主要结局
cardiac extracellular matrix remodelling
时间窗: 3-7 years
Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years
次要结局
- Cardiac and arterial phenotype(3-7 years)
研究者
研究点 (2)
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