HypertensionSSTTNCT06569589
Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat
An observational study of Hypertension and Primary Aldosteronism, run by Jens Titze at 4 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypertension, Primary Aldosteronism, Hypokalemia
- What is being tested?
- 23NaMRI Scan and Potassium Chloride (KCl)
- How many people
- 80 participants
- Where
- 4 sitesSingapore
- Study dates
- 27 Dec 2023to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 100 patients with hypertension with accompanying hypokalemia will be recruited from hospital sites.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marton Adriana, MD contact
Singapore4 sites, 4 recruiting
- Not yet recruiting
Singapore General Hospital
Singapore, 169608
Joanna Teo, Teo_Hwee_Ling@cgh.com.sg
Du Soon Swee
- Recruiting
Duke NUS Medical School
Singapore, 169857
Tzy Tiing Lim, tzytiing.lim@duke-nus.edu.sg
Jens Titze
- Recruiting
Changi General Hospital
Singapore, 529889
Joanna Teo, Teo_Hwee_Ling@cgh.com.sg
Troy Puar
- Not yet recruiting
Sengkang General Hospital
Singapore, 544886
Joanna Teo, Teo_Hwee_Ling@cgh.com.sg
Matthew Chuah
About this study
Official title: Tissue Sodium Quantification in Patients With Primary Aldosteronism
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.
Read the 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.
- Conditions
- Hypertension, Primary Aldosteronism, Hypokalemia
- Being tested
- 23NaMRI Scan, Potassium Chloride (KCl)
- Keywords
- NaMRI, muscle Na+ quantification, K+ supplementation
- Medical subject headings
- Hypertension, Hyperaldosteronism, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23NaMRI ScanDiagnostic test
23NaMRI, a non-invasive detection and quantification of hidden tissue Na+ stores in humans.
Potassium Chloride (KCl)Dietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Suspected PA | Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines. Receives: Diagnostic Test: 23NaMRI Scan; Dietary Supplement: Potassium Chloride (KCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start27 Dec 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Titze
- Sponsor type
- University, hospital or other
- Collaborators
- Changi General Hospital, Singapore General Hospital, Sengkang General Hospital
- Responsible party
- Sponsor-investigator, Jens Titze, Duke-NUS Graduate Medical School
- Investigators
- Jens Titze, MD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569589
- Sponsor's protocol ID
- 2023-1047
- Acronym
- SSTT
- Status last verified
- Jun 2025
- First submitted
- 1 Aug 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during study visits will be shared for participants who have provided informed consent for data sharing
Publications
Marton A, Saffari SE, Rauh M, Sun RN, Nagel AM, Linz P, Lim TT, Takase-Minegishi K, Pajarillaga A, Saw S, Morisawa N, Yam WK, Minegishi S, Totman JJ, Teo S, Teo LLY, Ng CT, Kitada K, Wild J, Kovalik JP, Luft FC, Greasley PJ, Chin CWL, Sim DKL, Titze J. Water Conservation Overrides Osmotic Diuresis During SGLT2 Inhibition in Patients With Heart Failure. J Am Coll Cardiol. 2024 Apr 16;83(15):1386-1398. doi: 10.1016/j.jacc.2024.02.020.
PubMed 38599715Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.
PubMed 22146510Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21.
PubMed 23339169Marton A, Tran HTN, Morisawa N, Osman I, Saffari SE, Lim TT, Yam WK, Chuah MB, Tay WL, Moy WL, Khong PL, Chin CWL, Nagel AM, Foo RSY, Luft FC, Finkelstein E, Kovalik JP, Rauh M, Puar T, Titze J. Oral KCl Supplementation Safely Reduces Body Na+ Surplus and Blood Pressure. Circ Res. 2026 Sep 28. doi: 10.1161/CIRCRESAHA.126.329131. Online ahead of print.
PubMed 42803000
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Sodium Quantification in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT06569589
- Acronym / sponsor ID
- SSTT / 2023-1047
- Conditions
- Hypertension, Primary Aldosteronism, Hypokalemia
- Keywords
- NaMRI, muscle Na+ quantification, K+ supplementation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jens TitzeUniversity, hospital or other
- Collaborators
- Changi General Hospital, Singapore General Hospital, Sengkang General Hospital
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected PA | – | Diagnostic Test: 23NaMRI Scan, Dietary Supplement: Potassium Chloride (KCl)Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 100 patients with hypertension with accompanying hypokalemia will be recruited from hospital sites.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Patients with exclusion criteria for the MRI, such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 23NaMRI Scan23NaMRI, a non-invasive detection and quantification of hidden tissue Na+ stores in humans. | Diagnostic test | Suspected PA |
| Potassium 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 | Dietary supplement | Suspected PA |
Primary outcome
Patients with primary aldosteronism have a 10-20% higher muscle Na+ content compared to healthy controls
Time frame: Baseline
Difference in muscle Na+ content as measured with 23NaMRI between patients with PA and healthy controls at baseline.
3 secondary outcomes
High K+ intake reduces muscle Na+ in patients with primary aldosteronism
Time frame: Baseline to 3 Months
MR blockade reduces muscle Na+ conten in patients with primary aldosteronism
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
Time frame: 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 38599715Marton A, Saffari SE, Rauh M, Sun RN, Nagel AM, Linz P, Lim TT, Takase-Minegishi K, Pajarillaga A, Saw S, Morisawa N, Yam WK, Minegishi S, Totman JJ, Teo S, Teo LLY, Ng CT, Kitada K, Wild J, Kovalik JP, Luft FC, Greasley PJ, Chin CWL, Sim DKL, Titze J. Water Conservation Overrides Osmotic Diuresis During SGLT2 Inhibition in Patients With Heart Failure. J Am Coll Cardiol. 2024 Apr 16;83(15):1386-1398. doi: 10.1016/j.jacc.2024.02.020.
- Results publication: PubMed 22146510Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.
- Results publication: PubMed 23339169Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21.
- Derived from this study: PubMed 42803000Marton A, Tran HTN, Morisawa N, Osman I, Saffari SE, Lim TT, Yam WK, Chuah MB, Tay WL, Moy WL, Khong PL, Chin CWL, Nagel AM, Foo RSY, Luft FC, Finkelstein E, Kovalik JP, Rauh M, Puar T, Titze J. Oral KCl Supplementation Safely Reduces Body Na+ Surplus and Blood Pressure. Circ Res. 2026 Sep 28. doi: 10.1161/CIRCRESAHA.126.329131. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during study visits will be shared for participants who have provided informed consent for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marton Adriana, MD contact
Jens Titze, MD principal investigator
Duke-NUS Graduate Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Primary Aldosteronism, run by Jens Titze at 4 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tzy Tiing Lim (+65 6516 7666, tzytiing.lim@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with primary aldosteronism have a 10-20% higher muscle Na+ content compared to healthy controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569589, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.