Primary Hyperaldosteronism Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Nephrology Department, University Hospital Erlangen | Erlangen | Bavaria |
Germany | Radiology Department, University Hospital Erlangen | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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 Ma — View Citation
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 Ja — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tissue potassium content | Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism | 3-6 months after intervention | |
Secondary | Blood pressure | Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism | 3-6 months after intervention | |
Secondary | Tissue sodium content | Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism | 3-6 months after intervention |
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