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

Not Applicable

Completed

• Conditions: Hypertension,Essential
• Interventions: Behavioral: Sodium restriction

• Registration Number: NCT05165823
• Lead Sponsor: Regional Hospital Holstebro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-21
• Study Start: 2022-02-08
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium restriction	Sodium restriction	-

Primary Outcome Measures

Name	Time	Method
Change in systolic 24-hour blood pressure	Measured before and after 4 weeks' intervention	Difference in systolic blood pressure measured before and after intervention

Trial Locations

Locations (1)

University Clinic in Nephrology and Hypertension; 🇩🇰 Herning, Denmark