Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

Obstructive Sleep Apnea of Adult Clinical Trial

— ROSA  

Official title:

Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06022133
• Other study ID #: BGH-5-2017
• Secondary ID: 1-10-72-253-17
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2023
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

• ?-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)

Related Conditions & MeSH terms

• Nocturnal Blood Pressure
• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive
• Sodium Imbalance

Intervention

Behavioral:
• Dietary sodium restriction
Selfemployed dietary sodium restriction

Locations

Country	Name	City	State
Denmark	University clinic in Nephrology and hypertension, Regional Hospital Godstrup	Godstrup	Herning
Denmark	Department of Medical Research and Medicine, Holstebro Regional Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Jesper Norgaard Bech

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nocturnal systolic blood pressure	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)	from day 14 to day 28
Secondary	Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)	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)	from day 14 to day 28
Secondary	Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)	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)	from day 14 to day 28
Secondary	Changes in day:night sodium urinary sodium excretion	Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)	from day 14 to day 28
Secondary	Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaC?)	Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)	from day 14 to day 28
Secondary	Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)	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)	from day 14 to day 28