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NCT Number: NCT04251780

Tissue K+ in Primary Hyperaldosteronism

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nephrology Department, University Hospital Erlangen, Erlangen, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients with Primary Aldosteronism:

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

Exclusion criteria

for patients with Primary Aldosteronism:

  • 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.

Inclusion criteria

for healthy control participants:

  • Age > 18 years

Exclusion criteria

for healthy control participants:

  • 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.

Treatment and study plan

Surgical Treatment of Primary Aldosteronism

Procedure

Surgery of an unilateral adrenal disease

Other names: Adrenalectomy

Drug treatment of Primary Aldosteronism

Drug

Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.

Other names: Medication

Primary outcomes

  1. Tissue potassium content

    Time frame: 3-6 months after intervention

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

Secondary outcomes

  1. Tissue sodium content

    Time frame: 3-6 months after intervention

    • Change in tissue sodium content measured by MRI before and after treatment of Primary Aldosteronism
    • Difference in tissue sodium content between patients with Primary Aldosteronism before treatment and healthy control subjects
  2. Blood pressure

    Time frame: 3-6 months after intervention

    Change in blood pressure (systolic/diastolic/mean) before and after treatment of Primary Aldosteronism

  3. Water balance

    Time frame: 3 - 6 months after intervention

    • Change in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy before and after treatment of Primary Aldosteronism
    • Difference in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy between patients with Primary Aldosteronism before treatment and healthy control subjects
  4. Pulse wave velocity

    Time frame: 3 - 6 months after intervention

    • Change in pulse wave velocity measured by SphygmoCor before and after treatment of Primary Aldosteronism
    • Difference in pulse wave velocity between patients with Primary Aldosteronism before treatment and healthy control subjects

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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