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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04251780
Other study ID # ConnK+
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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