Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Tissue potassium content
研究概览
简要总结
Recent human studies found tissue sodium storage in patients with hyperaldosteronism that could be detected non-invasively by 23Na-MRI. Tissue sodium accumulation could be mobilized upon treatment of hyperaldosteronism. Besides, former animal studies applying chemical electrolyte analysis indicate that this aldosterone induced sodium storage might be accompanied by intracellular potassium loss. Wether such an intracellular tissue potassium loss occurs in vivo in patients with hyperaldosteronism and if this deficiency can be corrected by treatment is unclear. The investigators will employ 39K-MR Imaging at 7Tesla to further assess this hypothesis.
详细描述
Patients diagnosed with primary hyperaldosteronism (PA) will be prospetively investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content (prospective observational study). Measurements will be conducted before treatment of hyperaldosteronism and three to four months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be assessed.
Additionally, we will conduct a case-control study and compare PA patients before treatment with age- and gender matched healthy control participants. In this study group 23Na-MRI and 39K-MRI at 7 Tesla will be conducted to assess tissue sodium and potassium content using the same MRI protocols as in PA patients. Blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be also examined.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with Primary Aldosteronism
Patients with primary Aldosteronism will either be treated by adrenalectomy (in case of unilateral adrenal disease) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as specified in the endocrinological guideline (J Clin Endocrinology & Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI.
干预措施: Surgical Treatment of Primary Aldosteronism (Procedure)
Patients with Primary Aldosteronism
Patients with primary Aldosteronism will either be treated by adrenalectomy (in case of unilateral adrenal disease) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as specified in the endocrinological guideline (J Clin Endocrinology & Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI.
干预措施: Drug treatment of Primary Aldosteronism (Drug)
结局指标
主要结局
Tissue potassium content
时间窗: 3-6 months after intervention
1. Change in tissue potassium content measured by MRI before and after treatment of Primary Aldosteronism 2. Difference in tissue potassium content between patients with Primary Aldosteronism before treatment and healthy control subjects
次要结局
- Tissue sodium content(3-6 months after intervention)
- Blood pressure(3-6 months after intervention)
- Water balance(3 - 6 months after intervention)
- Pulse wave velocity(3 - 6 months after intervention)