NCT06569589Recruiting
Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat
Tissue Sodium Quantification in Patients With Primary Aldosteronism
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study aims to provide quantitative facts on the pathophysiological changes in tissue Na+ content during Na+/K+ redistribution disorders in patients with PA in response to standard therapy. The investigators hypothesize that patients with primary aldosteronism have excessive Na+ storage in the muscle, which can now be quantified non-invasively using 23NaMRI. In analogy to the role of HbA1c as a metabolic long-term marker in diabetes, the quantifiable changes in muscle Na+ content may deliver the data evidence necessary to justify and conduct randomized diagnostic endpoint outcome trials in the future, with the ultimate aim to improve PA detection rate and treatment.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 1 Aug 2024
- Start date
- 27 Dec 2023
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Jens Titze
- Diseases
- High blood pressure
- NCT number
- NCT06569589
What you commit to
- Study type: Observational
- Planned participants: 80
- From 27 Dec 2023 to the primary completion date, 31 Mar 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with exclusion criteria for the MRI, such as:
- implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants)
- iron-based tattoos
- any other pieces of metal or devices that are not MR-Safe anywhere in the body
- patients who exhibit noticeable anxiety and/or claustrophobia into the MRI scanner
- pregnancy
- Diagnosis of heart failure NYHA classes III and IV
- Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia
- Patients with active cancer or severe comorbid conditions likely to compromise survival or study participation
Lab values
- Impaired renal function with eGFR\<30 ml/min or proteinuria \> 1 g/24h
Other
- Muscular dystrophies
- Unwillingness or other inability to cooperate
Who the study is looking for
- Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines.
- Male and female patients older than 21 years.
- Willingness to participate and ability to provide informed consent.
Age in the registry: 21 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changi General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Sengkang General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
| Duke NUS Medical School Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
Related publications
- Oral KCl Supplementation Safely Reduces Body Na+ Surplus and Blood Pressure.Circ Res · 2026 · PMID 42803000
This page is information, not medical advice. Discuss any trial with your doctor.