Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing (ROSA)

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult; Nocturnal Blood Pressure; Sodium Imbalance
• Intervention / Treatment: Behavioral: Dietary sodium restriction

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Department of Medical Research and Medicine, Holstebro Regional Hospital
  • Herning
    • Godstrup, Herning, Denmark, 7400
      • University clinic in Nephrology and hypertension, Regional Hospital Godstrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary sodium restriction; DIetary sodium restriction	Behavioral: Dietary sodium restriction; Selfemployed dietary sodium restriction
No Intervention: Usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)	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
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

Collaborators and Investigators

• Sponsor: Jesper Norgaard Bech
• Investigators: Principal Investigator: Bodil Hornstrup, M.D., Ph.D.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: BGH-5-2017; 1-10-72-253-17 (Other Identifier: The Scientific Ethical Committees for Central Denmark Region)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No