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Tissue K+ in Primary Hyperaldosteronism

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04251780
Enrollment
21
Registered
2020-02-05
Start date
2018-01-01
Completion date
2024-04-24
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrolyte Disturbance, Primary Hyperaldosteronism

Keywords

Hyperaldosteronism, Potassium, Magnetic Resonance Imaging

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 (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.

Interventions

PROCEDURESurgical Treatment of Primary Aldosteronism

Surgery of an unilateral adrenal disease

DRUGDrug treatment of Primary Aldosteronism

Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tissue potassium content3-6 months after intervention1. Change in tissue potassium content measured by MRI before and after treatment of Primary Aldosteronism 2. Difference in tissue potassium content between patients with Primary Aldosteronism before treatment and healthy control subjects

Secondary

MeasureTime frameDescription
Tissue sodium content3-6 months after intervention1. Change in tissue sodium content measured by MRI before and after treatment of Primary Aldosteronism 2. Difference in tissue sodium content between patients with Primary Aldosteronism before treatment and healthy control subjects
Blood pressure3-6 months after interventionChange in blood pressure (systolic/diastolic/mean) before and after treatment of Primary Aldosteronism
Water balance3 - 6 months after intervention1. Change in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy before and after treatment of Primary Aldosteronism 2. 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
Pulse wave velocity3 - 6 months after intervention1. Change in pulse wave velocity measured by SphygmoCor before and after treatment of Primary Aldosteronism 2. Difference in pulse wave velocity between patients with Primary Aldosteronism before treatment and healthy control subjects

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026