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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2023-07-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension,Essential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sodium restriction

Group Type EXPERIMENTAL

Sodium restriction

Intervention Type BEHAVIORAL

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.

Usual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No