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

Sponsor

Regional Hospital Holstebro (Other)

Overall Status

Recruiting

CT.gov ID

NCT05165823

Collaborator

(none)

Enrollment

Location

Arms

33.7

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential	Behavioral: Sodium restriction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 8, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sodium restriction	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.
No Intervention: Usual diet

Arm

Intervention/Treatment

Experimental: Sodium restriction

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.

No Intervention: Usual diet

Outcome Measures

Primary Outcome Measures

Change in systolic 24-hour blood pressure [Measured before and after 4 weeks' intervention]
Difference in systolic blood pressure measured before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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