The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients
VASA
1 other identifier
interventional
72
1 country
1
Brief Summary
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2021
CompletedFirst Posted
Study publicly available on registry
December 21, 2021
CompletedStudy Start
First participant enrolled
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2023
CompletedSeptember 22, 2023
September 1, 2023
1.4 years
December 7, 2021
September 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in systolic 24-hour blood pressure
Difference in systolic blood pressure measured before and after intervention
Measured before and after 4 weeks' intervention
Study Arms (2)
Sodium restriction
EXPERIMENTALUsual diet
NO INTERVENTIONInterventions
Participants will be guided in minimizing sodium intake. Guidance will be both oral and written. Bread with low sodium content will be offered to the participants.
Eligibility Criteria
You may qualify if:
- BMI ≤ 35 kg/m2
- Essential hypertension
- eGFR \> 15 ml/min/1,73m2
- Albumine-to-creatinine-ratio \< 500 mg/g
- Safe anticonception if women in childbearing age.
- Able to adhere to dietary regimen
You may not qualify if:
- Secondary hypertension
- Clinically significant heart failure (NYHA 3-4)
- Clinically significant liver disease
- Diabetes mellitus (type 1 and 2)
- Active cancer (except skin cancer)
- Renal transplant
- Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
- Proliferative glomerulonephritis or ANCA-related disease
- Continuous immunosuppressant treatment
- Pregnancy or lactation
- Alcohol abuse
- If the investigator finds the participant unfit to complete the project
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic in Nephrology and Hypertension
Herning, 7400, Denmark
Related Publications (1)
Duus CL, Nielsen SF, Hornstrup BG, Mose FH, Bech JN. Self-Performed Dietary Sodium Reduction and Blood Pressure in Patients With Essential Hypertension: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Jun 18;13(12):e034632. doi: 10.1161/JAHA.124.034632. Epub 2024 Jun 6.
PMID: 38842286DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Lundgreen Duus
University Clinic in Nephrology and Hypertension
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor, Ph.D.-student
Study Record Dates
First Submitted
December 7, 2021
First Posted
December 21, 2021
Study Start
February 8, 2022
Primary Completion
July 5, 2023
Study Completion
July 26, 2023
Last Updated
September 22, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share