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Completed

NCT Number: NCT06022133

Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

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

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Key information

Conditions

Sodium Imbalance Nocturnal Blood Pressure Obstructive Sleep Apnea of Adult

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University clinic in Nephrology and hypertension, Regional Hospital Godstrup, Gødstrup, Herning, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary sodium restriction

Behavioral

Selfemployed dietary sodium restriction

Primary outcomes

  1. Changes in nocturnal systolic blood pressure

    Time frame: 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 outcomes

  1. Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)

    Time frame: 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)

  2. Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)

    Time frame: 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)

  3. Changes in day:night sodium urinary sodium excretion

    Time frame: 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)

  4. Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)

    Time frame: 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)

  5. Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Jesper Norgaard Bech

Other

Registry information

Acronym: ROSA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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