Tissue K+ in Primary Hyperaldosteronism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI

Conditions
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Primary Hyperaldosteronism, Electrolyte Disturbance

Intervention / Treatment
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* Procedure: Surgical Treatment of Hyperaldosteronism
* Drug: Drug treatment of Hyperaldosteronism


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Primary Hyperaldosteronism diagnosed according to the endocrinological guidelines (J Clin Endocrinology & Metabolism, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Imaging Assessment before and after treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperaldosteronism treatment<br>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 Endocrinology & Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI. | Procedure: Surgical Treatment of Hyperaldosteronism<br>* Surgery of an Aldosterone-producing adenoma<br>* Other names: Adrenalectomy;Drug: Drug treatment of Hyperaldosteronism<br>* Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.<br>* Other names: Medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue potassium content | Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism | 3-6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism | 3-6 months after intervention | 
| Tissue sodium content | Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism | 3-6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperaldosteronism, Potassium, Magnetic Resonance Imaging