Surgical Treatment of Primary Aldosteronism
ProcedureSurgery of an unilateral adrenal disease
Other names: Adrenalectomy
NCT Number: NCT04251780
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.
Looking for future studies?
Notify Me18 year–95 year
All sexes
Observational
Nephrology Department, University Hospital Erlangen, Erlangen, Bavaria, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients with Primary Aldosteronism:
Exclusion criteria
for patients with Primary Aldosteronism:
Inclusion criteria
for healthy control participants:
Exclusion criteria
for healthy control participants:
Surgery of an unilateral adrenal disease
Other names: Adrenalectomy
Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.
Other names: Medication
Time frame: 3-6 months after intervention
Time frame: 3-6 months after intervention
Time frame: 3-6 months after intervention
Change in blood pressure (systolic/diastolic/mean) before and after treatment of Primary Aldosteronism
Time frame: 3 - 6 months after intervention
Time frame: 3 - 6 months after intervention
University of Erlangen-Nürnberg Medical School
Other
Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02934399
Acromegaly, Adrenal Gland Diseases
Athens, Greece
View Trial DetailsNCT03405025
Adrenal Gland Diseases, Adrenocortical Hyperfunction
Cambridge, United Kingdom
View Trial DetailsNCT01567111
Adrenal Cortex Diseases, Adrenal Cortex Neoplasms
Helsinki, Finland
View Trial DetailsNCT01978132
Adrenal Gland Diseases, Adrenocortical Hyperfunction
Nijmegen, Gelderland, Netherlands
View Trial Details