Tissue K+ in Primary Hyperaldosteronism
- Conditions
- Primary HyperaldosteronismElectrolyte Disturbance
- Interventions
- Procedure: Surgical Treatment of HyperaldosteronismDrug: Drug treatment of Hyperaldosteronism
- Registration Number
- NCT04251780
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Primary Hyperaldosteronism diagnosed according to the endocrinological guidelines (J Clin Endocrinology & Metabolism, May 2016)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hyperaldosteronism treatment Surgical Treatment of Hyperaldosteronism 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. Hyperaldosteronism treatment Drug treatment of Hyperaldosteronism 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.
- Primary Outcome Measures
Name Time Method Tissue potassium content 3-6 months after intervention Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism
- Secondary Outcome Measures
Name Time Method Blood pressure 3-6 months after intervention Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism
Tissue sodium content 3-6 months after intervention Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism
Trial Locations
- Locations (2)
Nephrology Department, University Hospital Erlangen
🇩🇪Erlangen, Bavaria, Germany
Radiology Department, University Hospital Erlangen
🇩🇪Erlangen, Bavaria, Germany