Sodium Storage in Singaporeans

NCT04319068 | Active Not Recruiting

• 1 other identifier: SSIS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy; Hypertension

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (2)

• Correlation between skin water loss and skin Na+ content

  3 years

• Skin water loss in hypertensive participants

  3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jens Titze: lead
• National Heart Centre Singapore: collaborator

Study Sites (2)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

Related Publications (5)

• 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.

  PMID: 23339169 BACKGROUND

• 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.

  PMID: 24401786 BACKGROUND

• 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.

  PMID: 28154199 BACKGROUND

• 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.

  PMID: 28515066 BACKGROUND

• 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.

  PMID: 28414302 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and Serum samples

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 24, 2020
• Study Start: July 2, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

SG (2)