Investigating potassium levels in patients with primary hyperaldosteronism
Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
This study is testing how potassium levels change in people with primary hyperaldosteronism before and after treatment to see how it affects their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 2 sites (Erlangen, Bavaria and 1 other locations) |
| Trial ID | NCT04251780 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the tissue potassium loss in patients diagnosed with primary hyperaldosteronism using advanced 39K-MR Imaging at 7 Tesla. Patients will undergo non-invasive imaging to assess tissue sodium and potassium content before and after treatment, which may include adrenal surgery or medication. The study will also evaluate blood pressure, body water distribution, serum electrolytes, and monocyte function to understand the effects of treatment on electrolyte balance.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with primary hyperaldosteronism according to endocrinological guidelines.
Not a fit: Patients with chronic kidney disease stage 3b or below, acute kidney injury, severe congestive heart failure, liver cirrhosis, pregnancy, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with primary hyperaldosteronism by addressing potassium deficiencies.
How similar studies have performed: While the approach of using advanced MRI techniques is innovative, previous studies have indicated potential for success in understanding electrolyte disturbances in similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Primary Hyperaldosteronism diagnosed according to the endocrinological guidelines (J Clin Endocrinology \& Metabolism, 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.
Where this trial is running
Erlangen, Bavaria and 1 other locations
- Nephrology Department, University Hospital Erlangen — Erlangen, Bavaria, Germany (Recruiting)
- Radiology Department, University Hospital Erlangen — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Christoph Kopp, MD — Nephrology Department, University Erlangen-Nurnberg, Germany
- Study coordinator: Christoph Kopp, MD
- Email: christoph.kopp@uk-erlangen.de
- Phone: +4991318539002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.