Quantifying sodium levels in muscles of patients with primary aldosteronism
Tissue Sodium Quantification in Patients With Primary Aldosteronism
This study is testing a new way to measure sodium levels in the muscles of people with primary aldosteronism to see if it helps improve understanding and treatment of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Duke-NUS Graduate Medical School Academic / other |
| Locations | 4 sites (Singapore and 3 other locations) |
| Trial ID | NCT06569589 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify tissue sodium content in patients with primary aldosteronism (PA) using a non-invasive technique called 23NaMRI. The researchers hypothesize that patients with PA have excessive sodium storage in their muscles, which can be measured to better understand the condition and monitor treatment efficacy. By providing quantitative data on sodium levels, the study seeks to improve the detection and management of PA, which is often underdiagnosed. The findings may pave the way for future randomized trials focused on improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-70 with arterial hypertension or suspected primary aldosteronism.
Not a fit: Patients with severe comorbid conditions, significant renal or liver disease, or those who cannot undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and treatment of primary aldosteronism, ultimately reducing cardiovascular risks for patients.
How similar studies have performed: While this approach is novel in the context of primary aldosteronism, similar non-invasive imaging techniques have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines. 2. Male and female patients older than 21 years. 3. Willingness to participate and ability to provide informed consent. Exclusion Criteria: 1. 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 2. Diagnosis of heart failure NYHA classes III and IV 3. Impaired renal function with eGFR\<30 ml/min or proteinuria \> 1 g/24h 4. Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia 5. Muscular dystrophies 6. Patients with active cancer or severe comorbid conditions likely to compromise survival or study participation 7. Unwillingness or other inability to cooperate
Where this trial is running
Singapore and 3 other locations
- Singapore General Hospital — Singapore, Singapore (Not_yet_recruiting)
- Duke NUS Medical School — Singapore, Singapore (Recruiting)
- Changi General Hospital — Singapore, Singapore (Recruiting)
- Sengkang General Hospital — Singapore, Singapore (Not_yet_recruiting)
Study contacts
- Principal investigator: Jens Titze, MD — Duke-NUS Graduate Medical School
- Study coordinator: Tzy Tiing Lim
- Email: tzytiing.lim@duke-nus.edu.sg
- Phone: +65 6516 7666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.