Status:

RECRUITING

Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat

Lead Sponsor:

Jens Titze

Collaborating Sponsors:

Changi General Hospital

Singapore General Hospital

Conditions:

Hypertension

Primary Aldosteronism

Eligibility:

All Genders

21-70 years

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 inv...

Detailed Description

Arterial hypertension is a major modifiable cardiovascular risk factor along with diabetes mellitus. Hypertension due to autonomous elevation in aldosterone production (Primary Aldosteronism; PA) is n...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 27 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 31 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06569589

Start Date

December 27 2023

End Date

August 31 2026

Last Update

June 6 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Singapore General Hospital

Singapore, Singapore, 169608

2

Duke NUS Medical School

Singapore, Singapore, 169857

3

Changi General Hospital

Singapore, Singapore, 529889

4

Sengkang General Hospital

Singapore, Singapore, 544886

Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat | DecenTrialz