Tissue K+ in Primary Hyperaldosteronism

NCT ID: NCT04251780

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2024-04-24

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 (PA) will be prospetively investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content (prospective observational study). Measurements will be conducted before treatment of hyperaldosteronism and three to four months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be assessed.

Additionally, we will conduct a case-control study and compare PA patients before treatment with age- and gender matched healthy control participants. In this study group 23Na-MRI and 39K-MRI at 7 Tesla will be conducted to assess tissue sodium and potassium content using the same MRI protocols as in PA patients. Blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be also examined.

Conditions

Primary Hyperaldosteronism; Electrolyte Disturbance

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Primary Aldosteronism

Patients with primary Aldosteronism will either be treated by adrenalectomy (in case of unilateral adrenal disease) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as specified in the endocrinological guideline (J Clin Endocrinology \& Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI.

Surgical Treatment of Primary Aldosteronism

Intervention Type: PROCEDURE

Surgery of an unilateral adrenal disease

Drug treatment of Primary Aldosteronism

Intervention Type: DRUG

Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.

Control group

Healthy participants, age- and gender-matched with the Primary Aldosteronism patients. Tissue sodium and tissue potassium amount of the healthy control group will be assessed by MRI and compared to the tissue sodium and potassium amount of the patients with Primary Aldosteronism before treatment.

No interventions assigned to this group

Interventions

Surgical Treatment of Primary Aldosteronism

Surgery of an unilateral adrenal disease

Intervention Type: PROCEDURE

Drug treatment of Primary Aldosteronism

Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.

Intervention Type: DRUG

Other Intervention Names

Adrenalectomy; Medication

Eligibility Criteria

Inclusion Criteria

• Primary Aldosteronism diagnosed according to the endocrinological guideline (J Clin Endocrinology & Metabolism, May 2016) without specific medication
• Age > 18 years

• Age > 18 years

Exclusion Criteria

• Chronic kidney disease ≤ 3b (estimated GFR <45 ml/min according to CKD-EPI)
• Active malignancy
• Severe congestive heart failure (NYHA III and IV)
• Liver cirrhosis (Child B and C)
• Acute infection
• Recent major surgical procedures (<3 months)
• Pregnancy
• Contraindications for MRI measurements: cardiac pacemaker, claustrophobia, etc.

• Medical history of chronic disease (such as diabetes, hypertension, chronic kidney disease etc.)
• regular medication
• blood pressure ≥ 140/90 mmHg
• Pregnancy
• Contraindications for MRI measurements: cardiac Pacemaker, claustrophobia, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Kopp, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Department, University Erlangen-Nurnberg, Germany

Locations

Nephrology Department, University Hospital Erlangen

Erlangen, Bavaria, Germany

Radiology Department, University Hospital Erlangen

Erlangen, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 22146510 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26934393 (View on PubMed)

Other Identifiers

ConnK+

Identifier Type: -

Identifier Source: org_study_id