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HealthySSISNCT04319068

Sodium Storage in Singaporeans

An observational study of Healthy and Hypertension, run by Jens Titze at 2 sites in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The overarching hypothesis of this study is that the kidney and the skin form an integrative network for water conservation, where Na+ storage is utilized to prevent body water loss, even at the expense of increased cardiovascular risk. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy, Hypertension
How many people
600 participants
Where
2 sitesSingapore
Study dates
2 Jul 2019to 31 Dec 2035
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Eligible participants from the Biobank cohort at the National Heart Centre, Singapore, will be screened and estimated 600 subjects (healthy controls and hypertensive patients) will be recruited for the study over a period of 3 years. No ethnic group or gender is targeted for or excluded from this reasearch.

Who may be able to join

  • Participants from the Biobank (Molecular and Imaging Studies of Cardiovascular Health and Disease) cohort in Singapore, who agreed to be contacted for further studies
  • 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
  • Pregnant women
Show all 15Show fewer
  • Diagnosis of heart failure NYHA classes III and IV
  • Impaired renal function with eGFR<45 ml/min or proteinuria > 0.5 g/24h
  • Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia
  • Peripheral oedema as assessed by the investigator
  • Active cancer
  • Patients who have received an organ or bone marrow transplant
  • Patients who have had major surgery in the past 3 months
  • Patients who have severe comorbid conditions likely to compromise survival or study participation
  • Unwillingness or other inability to cooperate

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

  • National Heart Centre Singapore

    Singapore, 169609

  • Duke-NUS Medical School

    Singapore, 169857

Other trials in Singapore

About this study

The overarching hypothesis of this study is that the kidney and the skin form an integrative network for water conservation, where Na+ storage is utilized to prevent body water loss, even at the expense of increased cardiovascular risk. The aim of this project is to characterise skin and muscle Na+ storage in a cohort designed to prospectively measure cardiovascular outcomes in Singaporeans, in order to determine whether humans with increased tissue Na+ storage have increased cardiovascular risk. To gain a better understanding of the mechanisms behind Na+ storage, the investigators will also test the hypothesis that participants with mutations of the skin protein filaggrin, who have increased water loss through the skin, will have increased skin Na+ storage and higher blood pressure levels.

Read the detailed description

Cardiovascular disease (CVD) occurs with increasing age and is the leading cause of death worldwide. A causal relationship between salt and CVD, although well established in animal models, has been difficult to prove in human populations. First, because humans do not live under the strict experimental conditions necessary to quantify sodium intake, and second, because tissue sodium stores cannot be detected with the available clinical methods, making reliable measurements of total body sodium extremely challenging.

The investigators have previously implemented 23NaMRI technology to detect and quantify tissue Na+ stores in humans. Previous studies have sown that humans store large amounts of Na+ in their skin and muscle as they age and that skin Na+ storage is linked with hypertension, while muscle Na+ storage is coupled with insulin resistance and diabetes. More recent studies show that the adverse effect of Na+ on human health goes far beyond the well-established salt-blood pressure relationship. The investigators have found that urea and/or Na+ storage in barriers such as kidney or skin is a key principle of water conservation.

This study aims to test the hypothesis that water conservation in the skin is essential for systemic fluid and blood pressure homeostasis, and that skin Na+ storage is utilized to prevent water loss, even at the expense of increased cardiovascular risk.

This is a cross-sectional study design with one study visit and a recruitment period of 3 years. 600 participants will be recruited from the Biobank cohort and tissue Na+ will be measured using 23NaMRI. The study will test whether increased Na+ storage in the skin is coupled with transepidermal water loss at the expense of high blood pressure levels, and examine the association between tissue sodium storage and specific cardiovascular markers.

Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04319068
Study groupRoleWhat they receive
HealthyEligible participants from the Biobank cohort at the National Heart Centre, Singapore, will be screened will be recruited for the study over a period of 3 years.
HypertensiveEligible participants from the Biobank cohort at the National Heart Centre, Singapore, will be screened will be recruited for the study over a period of 3 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin and muscle Na+ content

    Differences in skin and muscle Na+ content (measured with 23NaMRI) between healthy participants and hypertensive patients, overall and according to age, gender and race/ethnicity

    Measured: 3 years

Secondary outcomes (2)

  1. Correlation between skin water loss and skin Na+ content

    To show that participants with high transepidermal water loss (measured with Tewameter TM300) have higher skin sodium content (measured with 23NaMRI)

    Measured: 3 years

  2. Skin water loss in hypertensive participants

    To show that hypertensive participants have higher transepidermal water loss (measured with Tewameter TM300) and higher skin Na+ content than healthy participants

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2020
  2. Study start2 Jul 2019
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

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
Cross-sectional
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319068
Sponsor's protocol ID
SSIS
Acronym
SSIS
Status last verified
Aug 2026
First submitted
18 Mar 2020
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kopp 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 23339169

  • Titze J. Sodium balance is not just a renal affair. Curr Opin Nephrol Hypertens. 2014 Mar;23(2):101-5. doi: 10.1097/01.mnh.0000441151.55320.c3.

    PubMed 24401786

  • Schneider MP, Raff U, Kopp C, Scheppach JB, Toncar S, Wanner C, Schlieper G, Saritas T, Floege J, Schmid M, Birukov A, Dahlmann A, Linz P, Janka R, Uder M, Schmieder RE, Titze JM, Eckardt KU. Skin Sodium Concentration Correlates with Left Ventricular Hypertrophy in CKD. J Am Soc Nephrol. 2017 Jun;28(6):1867-1876. doi: 10.1681/ASN.2016060662. Epub 2017 Feb 2.

    PubMed 28154199

  • Titze J. Estimating salt intake in humans: not so easy! Am J Clin Nutr. 2017 Jun;105(6):1253-1254. doi: 10.3945/ajcn.117.158147. Epub 2017 May 17. No abstract available.

    PubMed 28515066

  • Rakova N, Kitada K, Lerchl K, Dahlmann A, Birukov A, Daub S, Kopp C, Pedchenko T, Zhang Y, Beck L, Johannes B, Marton A, Muller DN, Rauh M, Luft FC, Titze J. Increased salt consumption induces body water conservation and decreases fluid intake. J Clin Invest. 2017 May 1;127(5):1932-1943. doi: 10.1172/JCI88530. Epub 2017 Apr 17.

    PubMed 28414302

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Hypertension, run by Jens Titze at 2 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 15 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin and muscle Na+ content (time frame: 3 years). 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 NCT04319068, which also lists 5 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 28 Aug 2026.

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