Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat
Recruiting now
Conditions studied: Hypertension, Primary Aldosteronism, Hypokalemia
In brief
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.
Key facts
- Study ID
- NCT06569589
- Run by
- Jens Titze
- People needed
- 80
- Starts
- 2023-12-27
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-06-06
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Impaired renal function with eGFR<30 ml/min or proteinuria > 1 g/24h
- Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia
- Muscular dystrophies
- Patients with active cancer or severe comorbid conditions likely to compromise survival or study participation
- Unwillingness or other inability to cooperate
Where it is running
- Duke NUS Medical School — Singapore, Singapore (enrolling)
- Changi General Hospital — Singapore, Singapore (enrolling)
- Singapore General Hospital — Singapore, Singapore
- Sengkang General Hospital — Singapore, Singapore
Full record on ClinicalTrials.gov
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