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

Detailed Description

Patients diagnosed with primary hyperaldosteronism (PA) will be prospetively investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content (prospective observational study). Measurements will be conducted before treatment of hyperaldosteronism and three to four months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be assessed.

Additionally, we will conduct a case-control study and compare PA patients before treatment with age- and gender matched healthy control participants. In this study group 23Na-MRI and 39K-MRI at 7 Tesla will be conducted to assess tissue sodium and potassium content using the same MRI protocols as in PA patients. Blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be also examined.

• Study Type: Observational
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Nephrology Department, University Hospital Erlangen
    • Erlangen, Bavaria, Germany, 91054
      • Radiology Department, University Hospital Erlangen

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Primary Aldosteronism Healthy participants

Description

Inclusion Criteria for patients with Primary Aldosteronism:

• Primary Aldosteronism diagnosed according to the endocrinological guideline (J Clin Endocrinology & Metabolism, May 2016) without specific medication
• Age > 18 years

Exclusion Criteria for patients with Primary Aldosteronism:

• Chronic kidney disease ≤ 3b (estimated GFR <45 ml/min according to CKD-EPI)
• Active malignancy
• Severe congestive heart failure (NYHA III and IV)
• Liver cirrhosis (Child B and C)
• Acute infection
• Recent major surgical procedures (<3 months)
• Pregnancy
• Contraindications for MRI measurements: cardiac pacemaker, claustrophobia, etc.

Inclusion Criteria for healthy control participants:

- Age > 18 years

Exclusion Criteria for healthy control participants:

• Medical history of chronic disease (such as diabetes, hypertension, chronic kidney disease etc.)
• regular medication
• blood pressure ≥ 140/90 mmHg
• Pregnancy
• Contraindications for MRI measurements: cardiac Pacemaker, claustrophobia, etc.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Primary Aldosteronism; Patients with primary Aldosteronism will either be treated by adrenalectomy (in case of unilateral adrenal disease) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as specified in 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 Primary Aldosteronism; Surgery of an unilateral adrenal disease; Other Names: Adrenalectomy; Drug: Drug treatment of Primary Aldosteronism; Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.; Other Names: Medication
Control group; Healthy participants, age- and gender-matched with the Primary Aldosteronism patients. Tissue sodium and tissue potassium amount of the healthy control group will be assessed by MRI and compared to the tissue sodium and potassium amount of the patients with Primary Aldosteronism before treatment.

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 Primary Aldosteronism; Difference in tissue potassium content between patients with Primary Aldosteronism before treatment and healthy control subjects	3-6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue sodium content	Change in tissue sodium content measured by MRI before and after treatment of Primary Aldosteronism; Difference in tissue sodium content between patients with Primary Aldosteronism before treatment and healthy control subjects	3-6 months after intervention
Blood pressure	Change in blood pressure (systolic/diastolic/mean) before and after treatment of Primary Aldosteronism	3-6 months after intervention
Water balance	Change in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy before and after treatment of Primary Aldosteronism; Difference in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy between patients with Primary Aldosteronism before treatment and healthy control subjects	3 - 6 months after intervention
Pulse wave velocity	Change in pulse wave velocity measured by SphygmoCor before and after treatment of Primary Aldosteronism; Difference in pulse wave velocity between patients with Primary Aldosteronism before treatment and healthy control subjects	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 (Actual): April 24, 2024
• Study Completion (Actual): April 24, 2024

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 (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Potassium; Hyperaldosteronism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism; Pharmaceutical Preparations; Investigative Techniques; Surgical Procedures, Operative; Technology, Pharmaceutical; Endocrine Surgical Procedures; Dosage Forms; Adrenalectomy
• Other Study ID Numbers: ConnK+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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