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

September 21, 2023 updated by: Camilla Lundgreen Duus, Regional Hospital Holstebro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • University Clinic in Nephrology and Hypertension

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured before and after 4 weeks' intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Investigators

  • Principal Investigator: Camilla Lundgreen Duus, University Clinic in Nephrology and Hypertension

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2022

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 26, 2023

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD-2-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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