The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients

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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic in Nephrology and Hypertension

Herning, 7400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sodium restriction

Behavioral

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.

Primary outcomes

Change in systolic 24-hour blood pressure

Time frame: Measured before and after 4 weeks' intervention

Difference in systolic blood pressure measured before and after intervention

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension

Acronym: VASA

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 21, 2021
Registry last updated: Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed