Tissue K+ in Primary Hyperaldosteronism

NCT04251780 | Completed

• 1 other identifier: ConnK+
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Hyperaldosteronism; Electrolyte Disturbance

Keywords

Hyperaldosteronism; Potassium; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Tissue potassium content

  1. Change in tissue potassium content measured by MRI before and after treatment of Primary Aldosteronism 2. Difference in tissue potassium content between patients with Primary Aldosteronism before treatment and healthy control subjects

  3-6 months after intervention

Secondary Outcomes (4)

• Tissue sodium content

  3-6 months after intervention

• Blood pressure

  3-6 months after intervention

• Water balance

  3 - 6 months after intervention

• Pulse wave velocity

  3 - 6 months after intervention

Study Arms (2)

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.

Procedure: Surgical Treatment of Primary Aldosteronism; Drug: Drug treatment of Primary Aldosteronism

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.

Interventions

Surgical Treatment of Primary Aldosteronism PROCEDURE

Surgery of an unilateral adrenal disease

Also known as: Adrenalectomy

Patients with Primary Aldosteronism

Drug treatment of Primary Aldosteronism DRUG

Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.

Also known as: Medication

Patients with Primary Aldosteronism

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Primary Aldosteronism Healthy participants

You may qualify if:

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

You may not qualify if:

• 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.
• \- Age \> 18 years
• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (2)

Nephrology Department, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Radiology Department, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (2)

• 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.

  PMID: 22146510 RESULT

• 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.

  PMID: 26934393 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Adrenalectomy; Dosage Forms

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Christoph Kopp, MD

  Nephrology Department, University Erlangen-Nurnberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: January 1, 2018
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-09

Locations

DE (2)