Trials / Completed
CompletedNCT04251780
Tissue K+ in Primary Hyperaldosteronism
Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- University of Erlangen-Nürnberg Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical Treatment of Primary Aldosteronism | Surgery of an unilateral adrenal disease |
| DRUG | Drug treatment of Primary Aldosteronism | Treatment of Primary Aldosteronism with Spironolactone or Eplerenone. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2024-04-24
- Completion
- 2024-04-24
- First posted
- 2020-02-05
- Last updated
- 2025-11-25
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04251780. Inclusion in this directory is not an endorsement.