Nocturnal Blood Pressure, Obstructive Sleep Apnea of Adult, Sodium Imbalance
Conditions
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.
Interventions
BEHAVIORALDietary sodium restriction
Selfemployed dietary sodium restriction
Sponsors
Jesper Norgaard Bech
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Binding not possible as patients needs to carry out dietary sodium restriction themselves.
Intervention model description
Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in nocturnal systolic blood pressure | from day 14 to day 28 | Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic) | from day 14 to day 28 | Comparison of blood pressure measured by 24h blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
| Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI) | from day 14 to day 28 | Comparison of apnoea hypopnoea index measured by cardio respiratory monitoring at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
| Changes in day:night sodium urinary sodium excretion | from day 14 to day 28 | Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
| Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ) | from day 14 to day 28 | Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
| Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity) | from day 14 to day 28 | Comparison of biomarkers from blood samples drawn at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
Countries
Denmark
Outcome results
None listed