Clinical trial NCT04251780: Tissue K+ in Primary Hyperaldosteronism
Official title: Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Hyperaldosteronism
Electrolyte Disturbance
Keywords: Hyperaldosteronism
Potassium
Magnetic Resonance Imaging
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Imaging Assessment before and after treatment
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tissue potassium content
timeFrame: 3-6 months after intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: 3-6 months after intervention
measure: Tissue sodium content
timeFrame: 3-6 months after intervention
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Nephrology Department, University Hospital Erlangen
state: Bavaria
city: Erlangen
country: Germany
facility: Radiology Department, University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: Nephrology Department, University Erlangen-Nurnberg, Germany
name: Christoph Kopp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.
citation: Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.