Tissue K+ in Primary Hyperaldosteronism

Primary Hyperaldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251780
• Other study ID #: ConnK+
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Christoph Kopp, MD
• Phone: +4991318539002
• Email: christoph.kopp[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients diagnosed with primary hyperaldosteronism will be investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content. Measurements will be conducted before treatment of hyperaldosteronism and three months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), serum electrolytes as well as monocyte function will be assessed.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Electrolyte Disturbance
• Hyperaldosteronism
• Primary Hyperaldosteronism

Intervention

Procedure:
• Surgical Treatment of Hyperaldosteronism
Surgery of an Aldosterone-producing adenoma

Drug:
• Drug treatment of Hyperaldosteronism
Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.

Locations

Country	Name	City	State
Germany	Nephrology Department, University Hospital Erlangen	Erlangen	Bavaria
Germany	Radiology Department, University Hospital Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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

Outcome

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