An observational study in Hypertension, Primary Aldosteronism and Hypokalemia, sponsored by Jens Titze. Recruiting at 4 sites in Singapore. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Jens Titze · Observational
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 80 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Jens Titze is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Approximately 100 patients with hypertension with accompanying hypokalemia will be recruited from hospital sites.
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Exclusion Criteria:
Patients with exclusion criteria for the MRI, such as:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines.
Diagnostic Test: 23NaMRI Scan · Dietary Supplement: Potassium Chloride (KCl)
23NaMRI, a non-invasive detection and quantification of hidden tissue Na+ stores in humans.
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
Patients with primary aldosteronism have a 10-20% higher muscle Na+ content compared to healthy controls
Difference in muscle Na+ content as measured with 23NaMRI between patients with PA and healthy controls at baseline.
Time frame: Baseline
High K+ intake reduces muscle Na+ in patients with primary aldosteronism
Change in muscle Na+ content as measured with 23NaMRI, 3 months after initiation of K+ supplementation
Time frame: Baseline to 3 Months
MR blockade reduces muscle Na+ conten in patients with primary aldosteronism
Change in muscle Na+ content as measured with 23NaMRI, 12-18 months after initiation of MR blockade treatment
Time frame: Baseline to 18 months
Compared to MR blockade, adenoma surgical removal is more efficient in reducing muscle Na+ in patients with primary aldosteronism
Change in muscle Na+ content as measured with 23NaMRI after adenoma surgical removal compared to MR blockade treatment.
Time frame: 36 Months
Plan to share: Yes — De-identified individual participant data (IPD) collected during study visits will be shared for participants who have provided informed consent for data sharing
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: 2 years after article publication with no end date
Access criteria: Access will be granted upon reasonable request, provided that interested researchers have a scientific hypothesis for which they submit a methodologically sound proposal, including clearly defined research hypothesis and a statistical analysis plan.
Started Dec 2023 (actual). Primary completion is estimated for Mar 2026, 27 months after the start.
Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's planned 27 months is below that.
Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.
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Jens Titze