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

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ClinicalTrials.gov Identifier: NCT06022133
Recruitment Status : Completed
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Jesper Norgaard Bech, Regional Hospital Holstebro

Study Description
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Brief Summary:
A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.

Condition or disease Intervention/treatment Phase
Sodium Imbalance Nocturnal Blood Pressure Obstructive Sleep Apnea of Adult Behavioral: Dietary sodium restriction Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
Masking: None (Open Label)
Masking Description: Binding not possible as patients needs to carry out dietary sodium restriction themselves.
Primary Purpose: Treatment
Official Title: Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary sodium restriction
DIetary sodium restriction
 Behavioral: Dietary sodium restriction
Selfemployed dietary sodium restriction
No Intervention: Usual diet
Usual diet


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022133


Locations
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Denmark
University clinic in Nephrology and hypertension, Regional Hospital Godstrup
Godstrup, Herning, Denmark, 7400
Department of Medical Research and Medicine, Holstebro Regional Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Jesper Norgaard Bech
Investigators
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Principal Investigator: Bodil Hornstrup M.D., Ph.D.
More Information
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Responsible Party: Jesper Norgaard Bech, M.D., PhD, head of University Clinic in Nephrology and Hypertension, Regeional Hospital Vest Justland and Aarhus university, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT06022133    
Other Study ID Numbers: BGH-5-2017
1-10-72-253-17 ( Other Identifier: The Scientific Ethical Committees for Central Denmark Region )
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases