Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat
Recruiting · NCT06569589 · Observational (researchers observe without assigning treatment) · Lead sponsor: Jens Titze
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
4 locations listed.
- Singapore General Hospital - Singapore, Singapore
- Duke NUS Medical School - Singapore, Singapore
- Changi General Hospital - Singapore, Singapore
- Sengkang General Hospital - Singapore, Singapore