Clinical trial NCT06022133: Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Official title: Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sodium Imbalance
Nocturnal Blood Pressure
Obstructive Sleep Apnea of Adult
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in nocturnal systolic blood pressure
timeFrame: from day 14 to day 28
Secondary outcomes:
measure: Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)
timeFrame: from day 14 to day 28
measure: Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)
timeFrame: from day 14 to day 28
measure: Changes in day:night sodium urinary sodium excretion
timeFrame: from day 14 to day 28
measure: Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)
timeFrame: from day 14 to day 28
measure: Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)
timeFrame: from day 14 to day 28
Other outcomes:
Locations:
city: Godstrup
country: Denmark
facility: University clinic in Nephrology and hypertension, Regional Hospital Godstrup
state: Herning
city: Holstebro
country: Denmark
facility: Department of Medical Research and Medicine, Holstebro Regional Hospital
Study officials:
affiliation: M.D., Ph.D.
name: Bodil Hornstrup
role: PRINCIPAL_INVESTIGATOR
References: