NCT06569589 Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat
| NCT ID | NCT06569589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jens Titze |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-12-27 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jens Titze, MD
PRINCIPAL INVESTIGATOR
Duke-NUS Graduate Medical School
Frequently Asked Questions
Who can join the NCT06569589 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06569589 currently recruiting?
Yes, NCT06569589 is actively recruiting participants. Contact the research team at tzytiing.lim@duke-nus.edu.sg for enrollment information.
Where is the NCT06569589 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore, Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT06569589 clinical trial?
NCT06569589 is sponsored by Jens Titze. The principal investigator is Jens Titze, MD at Duke-NUS Graduate Medical School. The trial plans to enroll 80 participants.