Tissue K+ in Primary Hyperaldosteronism

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狀態招聘中

贊助商

University of Erlangen-Nürnberg Medical School

臨床試驗: NCT04251780

BioSeek: nct04251780

關鍵詞

抽象

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.

描述

Patients diagnosed with primary hyperaldosteronism will be investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content. Measurements will be conducted before treatment of hyperaldosteronism and three months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), serum electrolytes as well as monocyte function will be assessed.

日期

最後驗證:	01/31/2020
首次提交:	01/29/2020
提交的預估入學人數:	01/30/2020
首次發布:	02/04/2020
上次提交的更新:	02/02/2020
最近更新發布:	02/04/2020
實際學習開始日期:	12/31/2017
預計主要完成日期:	07/30/2020
預計完成日期:	09/29/2020

狀況或疾病

Primary Hyperaldosteronism

Electrolyte Disturbance

干預/治療

Procedure: Hyperaldosteronism treatment

Drug: Hyperaldosteronism treatment

相

手臂組

臂	干預/治療
Experimental: Hyperaldosteronism treatment Patients with Hyperaldosteronism will either be treated by adrenalectomy (adrenal adenoma) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as indicated by the Endocrinological Guideline (J Clin Endocrinol Metab, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI.	Procedure: Hyperaldosteronism treatment Surgery of an Aldosterone-producing adenoma

資格標準

有資格學習的年齡	18 Years 至 18 Years
有資格學習的性別	All
接受健康志願者	是
標準	Inclusion Criteria: - Primary Hyperaldosteronism diagnosed according to the endocrinological guidelines (J Clin Endocrinol Metab, May 2016) Exclusion Criteria: - Chronic kidney disease stage 3b and below (estimated GFR <30 ml/min according to CKD-EPI) - Acute kidney injury - Severe congestive heart failure (NYHA III and IV) - Liver Cirrhosis (Child B and C) - Pregnancy - Contraindications for MRI measurements: cardiac Pacemaker, claustrophobia, etc.

結果

主要結果指標

1. Tissue potassium content [3-6 months after intervention]

Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism

次要成果指標

1. Blood pressure [3-6 months after intervention]

Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism

2. Tissue sodium content [3-6 months after intervention]

Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism

Tissue K+ in Primary Hyperaldosteronism

關鍵詞

potassium

hyperaldosteronism

抽象

描述

日期

狀況或疾病

干預/治療

相

手臂組

資格標準

結果

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