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

Hypertension,Essential Clinical Trial

— VASA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165823
• Other study ID #: CLD-2-2021
• Status: Completed
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: July 26, 2023

Study information

• Verified date: September 2023
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 26, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Behavioral:
• Sodium restriction
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.

Locations

Country	Name	City	State
Denmark	University Clinic in Nephrology and Hypertension	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic 24-hour blood pressure	Difference in systolic blood pressure measured before and after intervention	Measured before and after 4 weeks' intervention