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Trials / Completed

CompletedNCT04251780

Tissue K+ in Primary Hyperaldosteronism

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

Status
Completed
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
University of Erlangen-Nürnberg Medical School · Academic / Other
Sex
All
Age
18 Years – 95 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgical Treatment of Primary AldosteronismSurgery of an unilateral adrenal disease
DRUGDrug treatment of Primary AldosteronismTreatment of Primary Aldosteronism with Spironolactone or Eplerenone.

Timeline

Start date
2018-01-01
Primary completion
2024-04-24
Completion
2024-04-24
First posted
2020-02-05
Last updated
2025-11-25

Locations

2 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT04251780. Inclusion in this directory is not an endorsement.