Quantifying sodium levels in muscles of patients with primary aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Duke NUS Medical School
  Singapore, Singapore Recruiting
• Changi General Hospital
  Singapore, Singapore Recruiting
• Singapore General Hospital
  Singapore, Singapore Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Improving screening for primary aldosteronism in patients with hypertension

  This study is testing if giving a small dose of dexamethasone can help doctors better identify primary aldosteronism in patients with high blood pressure who are already on medication.

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• Combining statins with amlodipine to treat primary aldosteronism

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• Impact of Aldosterone Blockade on Heart Function in Primary Aldosteronism

  This study is testing if a medication that blocks a hormone called aldosterone can improve heart function in people with primary aldosteronism, which causes high blood pressure.

  Recruiting Phase 4 Brigham and Women's Hospital · Boston, Massachusetts · NCT05030545

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.