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Sodium Storage in Singaporeans (SSIS)

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ClinicalTrials.gov Identifier: NCT04319068
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Heart Centre Singapore
Information provided by (Responsible Party):
Jens Titze, Duke-NUS Graduate Medical School

Brief 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. 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.

Condition or disease
Healthy Hypertension

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sodium Storage in Singaporeans
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy
Eligible 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.
Hypertensive
Eligible 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



Primary Outcome Measures :
  1. Skin and muscle Na+ content [ Time Frame: 3 years ]
    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


Secondary Outcome Measures :
  1. Correlation between skin water loss and skin Na+ content [ Time Frame: 3 years ]
    To show that participants with high transepidermal water loss (measured with Tewameter TM300) have higher skin sodium content (measured with 23NaMRI)

  2. Skin water loss in hypertensive participants [ Time Frame: 3 years ]
    To show that hypertensive participants have higher transepidermal water loss (measured with Tewameter TM300) and higher skin Na+ content than healthy participants


Biospecimen Retention:   Samples Without DNA
Urine and Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Participants from the Biobank (Molecular and Imaging Studies of Cardiovascular Health and Disease) cohort in Singapore, who agreed to be contacted for further studies
  2. Male and female patients older than 21 years
  3. Willingness to participate and ability to provide informed consent

Exclusion Criteria:

  1. Patients with exclusion criteria for the MRI, such as:

    1. implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants)
    2. iron-based tattoos
    3. any other pieces of metal or devices that are not MR-Safe anywhere in the body
    4. patients who exhibit noticeable anxiety and/or claustrophobia into the MRI scanner
  2. Pregnant women
  3. Diagnosis of heart failure NYHA classes III and IV
  4. Impaired renal function with eGFR<45 ml/min or proteinuria > 0.5 g/24h
  5. Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia
  6. Peripheral oedema as assessed by the investigator
  7. Active cancer
  8. Patients who have received an organ or bone marrow transplant
  9. Patients who have had major surgery in the past 3 months
  10. Patients who have severe comorbid conditions likely to compromise survival or study participation
  11. Unwillingness or other inability to cooperate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319068


Contacts
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Contact: Adriana Marton, MD 6516 7666 adriana.marton@duke-nus.edu.sg
Contact: TzyTiing Lim, BSC tzytiing.lim@duke-nus.edu.sg

Locations
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Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Katherina Oh       katherina.oh@nhcs.com.sg   
Principal Investigator: Calvin Chin, MD         
Duke-NUS Medical School Active, not recruiting
Singapore, Singapore, 169857
Sponsors and Collaborators
Jens Titze
National Heart Centre Singapore
Publications:
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Responsible Party: Jens Titze, Associate Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT04319068    
Other Study ID Numbers: SSIS
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases