Tissue K+ in Primary Hyperaldosteronism

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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Hyperaldosteronism; Electrolyte Disturbance
• Intervention / Treatment: Procedure: Surgical Treatment of Hyperaldosteronism; Drug: Drug treatment of Hyperaldosteronism

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Kopp, MD; Phone Number: +4991318539002; Email: christoph.kopp@uk-erlangen.de
• Study Contact Backup: Name: Armin Nagel, PhD; Phone Number: +4991318525900; Email: armin.nagel@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Nephrology Department, University Hospital Erlangen
      • Contact: Christoph Kopp, MD; Phone Number: 0049 9131 8539002; Email: christoph.kopp@uk-erlangen.de
      • Contact: Anke Dahlmann, MD; Phone Number: 0049 9131 8539002; Email: anke.dahlmann@uk-erlangen.de
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Radiology Department, University Hospital Erlangen
      • Contact: Armin Nagel, PhD; Phone Number: +4991318525900; Email: armin.nagel@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Endocrinology & Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI.

Procedure: Surgical Treatment of Hyperaldosteronism; Surgery of an Aldosterone-producing adenoma; Other Names: Adrenalectomy; Drug: Drug treatment of Hyperaldosteronism; Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.; Other Names: Medication

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Christoph Kopp, MD, Nephrology Department, University Erlangen-Nurnberg, Germany

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Potassium; Hyperaldosteronism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: ConnK+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No