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

Tissue Sodium Quantification in Patients With Primary Aldosteronism

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06569589
Acronym
SSTT
Enrollment
80
Registered
2024-08-26
Start date
2023-12-27
Completion date
2026-08-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Primary Aldosteronism, Hypokalemia

Keywords

NaMRI, muscle Na+ quantification, K+ supplementation

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.

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 not responsive to usual antihypertensive medications and is dramatically underdiagnosed in standard clinical routine. Currently, only 0.1% (1,280,000 worldwide and 1,140 Singaporeans) are diagnosed, much lower than the 5-20% (64,000,000-256,000,000 worldwide and 57,000-228,000 Singaporeans) of all patients with arterial hypertension estimated to suffer from PA. Given the high prevalence of PA, low rates of diagnoses, high cardiometabolic morbidity and mortality associated with untreated PA, the detection of more patients with PA is obligatory, and treatment success must be monitored. The investigators hypothesize that patients with primary aldosteronism have excessive Na+ storage in the muscle, which can now be quantified non-invasively using 23NaMRI. This study will be the first to systematically quantify changes in muscle Na+ stores in these patients in response to standard therapy. There is currently no established clinical diagnostic tool to detect or quantify the underlying cellular Na+/K+ redistribution physiology in patients with PA. Seeing and quantifying the Na+ non-invasively with 23NaMRI will provide a fresh look into the pathophysiological principles of solute and fluid homeostasis to evaluate therapy efficacy, and to improve rates of PA diagnoses with an intention to cure. This is a prospective non-randomized multi-centre study with 3 study visits ( pre-potassium treatment, pre- diagnosis and post-treatment) over a study period of 3 years. Approximately 100 participants will be recruited from hospital sites. The purpose of the study is to detect and quantify a hidden pathophysiological Na+/K+ redistribution process at the tissue level, using 23NaMRI, in an effort to provide an alternative to traditional hormone and solute diagnostics in blood and urine.

Interventions

DIAGNOSTIC_TEST23NaMRI Scan

23NaMRI, a non-invasive detection and quantification of hidden tissue Na+ stores in humans.

DIETARY_SUPPLEMENTPotassium Chloride (KCl)

K+ supplementation intervention is given participants as part of their standard care. In this trial the K+ supplementation dosage is standardized and adjusted based on blood K+ level

Sponsors

Changi General Hospital
CollaboratorOTHER
Singapore General Hospital
CollaboratorOTHER
Sengkang General Hospital
CollaboratorOTHER
Jens Titze
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients with primary aldosteronism have a 10-20% higher muscle Na+ content compared to healthy controlsBaselineDifference in muscle Na+ content as measured with 23NaMRI between patients with PA and healthy controls at baseline.

Secondary

MeasureTime frameDescription
High K+ intake reduces muscle Na+ in patients with primary aldosteronismBaseline to 3 MonthsChange in muscle Na+ content as measured with 23NaMRI, 3 months after initiation of K+ supplementation
MR blockade reduces muscle Na+ conten in patients with primary aldosteronismBaseline to 18 monthsChange in muscle Na+ content as measured with 23NaMRI, 12-18 months after initiation of MR blockade treatment
Compared to MR blockade, adenoma surgical removal is more efficient in reducing muscle Na+ in patients with primary aldosteronism36 MonthsChange in muscle Na+ content as measured with 23NaMRI after adenoma surgical removal compared to MR blockade treatment.

Countries

Singapore

Contacts

Primary ContactTzy Tiing Lim
tzytiing.lim@duke-nus.edu.sg+65 6516 7666
Backup ContactMarton Adriana, MD
adriana.marton@duke-nus.edu.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026