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Tissue K+ in Primary Hyperaldosteronism

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ClinicalTrials.gov Identifier: NCT04251780
Recruitment Status : Unknown
Verified November 2020 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : February 5, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Primary Hyperaldosteronism Electrolyte Disturbance Procedure: Surgical Treatment of Hyperaldosteronism Drug: Drug treatment of Hyperaldosteronism Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Imaging Assessment before and after treatment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyperaldosteronism treatment
Patients with Hyperaldosteronism will either be treated by adrenalectomy (adrenal adenoma) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as indicated by the Endocrinological Guideline (J Clin Endocrinol Metab, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI.
 Procedure: Surgical Treatment of Hyperaldosteronism
Surgery of an Aldosterone-producing adenoma
Other Name: Adrenalectomy

Drug: Drug treatment of Hyperaldosteronism
Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.
Other Name: Medication


Outcome Measures
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Primary Outcome Measures :
  1. Tissue potassium content [ Time Frame: 3-6 months after intervention ]
    Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 3-6 months after intervention ]
    Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism

  2. Tissue sodium content [ Time Frame: 3-6 months after intervention ]
    Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Primary Hyperaldosteronism diagnosed according to the endocrinological guidelines (J Clin Endocrinol Metab, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251780


Contacts
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Contact: Christoph Kopp, MD +4991318539002 christoph.kopp@uk-erlangen.de
Contact: Armin Nagel, PhD +4991318525900 armin.nagel@uk-erlangen.de

Locations
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Germany
Nephrology Department, University Hospital Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Christoph Kopp, MD    0049 9131 8539002    christoph.kopp@uk-erlangen.de   
Contact: Anke Dahlmann, MD    0049 9131 8539002    anke.dahlmann@uk-erlangen.de   
Radiology Department, University Hospital Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Armin Nagel, PhD    +4991318525900    armin.nagel@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Christoph Kopp, MD Nephrology Department, University Erlangen-Nurnberg, Germany
More Information
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Publications of Results:

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04251780    
Other Study ID Numbers: ConnK+
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Hyperaldosteronism
Potassium
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases