Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2021-03-31

Brief Summary

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A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.

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Detailed Description

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A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Patients with hypertension resistant of antihypertensive treatment have a high frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal pauses in breathing in this patients population.

Conditions

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Sodium Imbalance Nocturnal Blood Pressure Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Binding not possible as patients needs to carry out dietary sodium restriction themselves.

Study Groups

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Dietary sodium restriction

DIetary sodium restriction

Group Type EXPERIMENTAL

Dietary sodium restriction

Intervention Type BEHAVIORAL

Selfemployed dietary sodium restriction

Usual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary sodium restriction

Selfemployed dietary sodium restriction

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 24h blood pressure \> 130/80 mmHg under antihypertensive treatment with three agent, one of these being diuretic. Blood pressure measurement completed after observed intake of antihypertensive medication.
* unchanged antihypertensive treatment for three months
* estimated glomerular function \>45 mL/min/1.73 m2

Exclusion Criteria

* Heart failure assessed from NYHA classification (grade 3-4)
* Presence of clinically significant peripheral edema
* In treatment for obstructive sleep apnea
* Chronic obstructive pulmonary disease (FEV1 \<50%)
* Antihypertensive therapy that can not be taken once daily
* Pregnancy or breastfeeding
* Β-albumin \<34 g / l
* U-albumin creatinine ratio\> 1000 mg / g
* INR\> 1.2 (if marevan treatment: ALAT\> 200)
* Gluten allergy (dietary guidelines are not adjusted to this group)

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No