Tissue K+ in Primary Hyperaldosteronism (NCT04251780) | Clinical Trial Compass
CompletedNot Applicable
Tissue K+ in Primary Hyperaldosteronism
Germany21 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tissue potassium content
Timeframe: 3-6 months after intervention
Trial details
NCT IDNCT04251780
SponsorUniversity of Erlangen-Nürnberg Medical School