Tissue K+ in Primary Hyperaldosteronism

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Primary Hyperaldosteronism; Electrolyte Disturbance

Treatments: Drug: Drug treatment of Hyperaldosteronism; Procedure: Surgical Treatment of Hyperaldosteronism

Study type: Interventional

Funder types: Other

Identifiers

NCT04251780

ConnK+

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Hyperaldosteronism treatment

Experimental group

Description:

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.

Treatment:

Procedure: Surgical Treatment of Hyperaldosteronism

Drug: Drug treatment of Hyperaldosteronism