Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

Not Applicable

Completed

• Conditions: Nocturnal Blood Pressure; Obstructive Sleep Apnea of Adult; Sodium Imbalance
• Interventions: Behavioral: Dietary sodium restriction

• Registration Number: NCT06022133
• Lead Sponsor: Jesper Norgaard Bech

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.

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2020-04-23
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dietary sodium restriction	Dietary sodium restriction	DIetary sodium restriction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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 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 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)

Trial Locations

Locations (2)

University clinic in Nephrology and hypertension, Regional Hospital Godstrup; 🇩🇰 Godstrup, Herning, Denmark

Department of Medical Research and Medicine, Holstebro Regional Hospital; 🇩🇰 Holstebro, Denmark