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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary sodium restriction
Sponsored by
Jesper Norgaard Bech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sodium Imbalance

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dietary sodium restriction

Usual diet

Arm Description

DIetary sodium restriction

Usual diet

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)

Full Information

First Posted
April 23, 2020
Last Updated
August 28, 2023
Sponsor
Jesper Norgaard Bech
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1. Study Identification

Unique Protocol Identification Number
NCT06022133
Brief Title
Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Acronym
ROSA
Official Title
Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jesper Norgaard Bech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sodium Imbalance, Nocturnal Blood Pressure, Obstructive Sleep Apnea of Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary sodium restriction
Arm Type
Experimental
Arm Description
DIetary sodium restriction
Arm Title
Usual diet
Arm Type
No Intervention
Arm Description
Usual diet
Intervention Type
Behavioral
Intervention Name(s)
Dietary sodium restriction
Intervention Description
Selfemployed dietary sodium restriction
Primary Outcome Measure Information:
Title
Changes in nocturnal systolic blood pressure
Description
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)
Time Frame
from day 14 to day 28
Secondary Outcome Measure Information:
Title
Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)
Description
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)
Time Frame
from day 14 to day 28
Title
Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)
Description
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)
Time Frame
from day 14 to day 28
Title
Changes in day:night sodium urinary sodium excretion
Description
Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
Time Frame
from day 14 to day 28
Title
Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)
Description
Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
Time Frame
from day 14 to day 28
Title
Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)
Description
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)
Time Frame
from day 14 to day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Hornstrup
Organizational Affiliation
M.D., Ph.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University clinic in Nephrology and hypertension, Regional Hospital Godstrup
City
Godstrup
State/Province
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Department of Medical Research and Medicine, Holstebro Regional Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

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