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Clinical trial

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

ID
Name
ConnK+
Description
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.
Trial arms
Trial start
2018-01-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Treatment
Surgical Treatment of Hyperaldosteronism
Surgery of an Aldosterone-producing adenoma
Arms:
Hyperaldosteronism treatment
Other names:
Adrenalectomy
Drug treatment of Hyperaldosteronism
Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.
Arms:
Hyperaldosteronism treatment
Other names:
Medication
Size
10
Primary endpoint
Tissue potassium content
3-6 months after intervention
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Imaging Assessment before and after treatment', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-10-30

1 organization

1 product

2 indications

Organization
University of Erlangen-Nürnberg Medical School
Product
Hyperaldosteronism
Indication
Primary Aldosteronism
Indication
Electrolyte Disturbance