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Tissue K+ in Primary Hyperaldosteronism

Primary Purpose

Primary Hyperaldosteronism, Electrolyte Disturbance

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Surgical Treatment of Hyperaldosteronism
Drug treatment of Hyperaldosteronism
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Hyperaldosteronism focused on measuring Hyperaldosteronism, Potassium, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nephrology Department, University Hospital ErlangenRecruiting
  • Radiology Department, University Hospital ErlangenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperaldosteronism treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Tissue potassium content
Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism

Secondary Outcome Measures

Blood pressure
Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism
Tissue sodium content
Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism

Full Information

First Posted
January 30, 2020
Last Updated
November 28, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04251780
Brief Title
Tissue K+ in Primary Hyperaldosteronism
Official Title
Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperaldosteronism, Electrolyte Disturbance
Keywords
Hyperaldosteronism, Potassium, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Imaging Assessment before and after treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperaldosteronism treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical Treatment of Hyperaldosteronism
Other Intervention Name(s)
Adrenalectomy
Intervention Description
Surgery of an Aldosterone-producing adenoma
Intervention Type
Drug
Intervention Name(s)
Drug treatment of Hyperaldosteronism
Other Intervention Name(s)
Medication
Intervention Description
Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.
Primary Outcome Measure Information:
Title
Tissue potassium content
Description
Change in tissue potassium content measured by MRI before and after treatment of hyperaldosteronism
Time Frame
3-6 months after intervention
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change in blood pressure (systolic/diastolic/mean) before and after treatment of hyperaldosteronism
Time Frame
3-6 months after intervention
Title
Tissue sodium content
Description
Change in tissue sodium content measured by MRI before and after treatment of hyperaldosteronism
Time Frame
3-6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Kopp, MD
Phone
+4991318539002
Email
christoph.kopp@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Armin Nagel, PhD
Phone
+4991318525900
Email
armin.nagel@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Kopp, MD
Organizational Affiliation
Nephrology Department, University Erlangen-Nurnberg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Department, University Hospital Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Kopp, MD
Phone
0049 9131 8539002
Email
christoph.kopp@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Anke Dahlmann, MD
Phone
0049 9131 8539002
Email
anke.dahlmann@uk-erlangen.de
Facility Name
Radiology Department, University Hospital Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Nagel, PhD
Phone
+4991318525900
Email
armin.nagel@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22146510
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 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.
Results Reference
result
PubMed Identifier
26934393
Citation
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 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
Results Reference
result

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Tissue K+ in Primary Hyperaldosteronism

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