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

Regional Hospital Holstebro

Status: Completed

Conditions: Hypertension,Essential

Treatments: Behavioral: Sodium restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT05165823

CLD-2-2021

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Sodium restriction

Experimental group

Treatment:

Behavioral: Sodium restriction

Usual diet

No Intervention group