Sodium ImbalanceROSANCT06022133
Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
A study testing Dietary sodium restriction in people with Sodium Imbalance and Nocturnal Blood Pressure, run by Jesper Norgaard Bech at 2 sites in Denmark.
Trial summary
A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Sodium Imbalance, Nocturnal Blood Pressure, Obstructive Sleep Apnea of Adult
- What is being tested?
- Dietary sodium restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesDenmark
- Study dates
- 3 Jan 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University clinic in Nephrology and hypertension, Regional Hospital Godstrup
Gødstrup, Herning, 7400
Department of Medical Research and Medicine, Holstebro Regional Hospital
Holstebro, 7500
About this study
A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.
Read the 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.
- Being tested
- Dietary sodium restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary sodium restrictionBehavioural
Selfemployed dietary sodium restriction
| Study group | Role | What they receive |
|---|---|---|
| Dietary sodium restriction | Experimental | DIetary sodium restriction Receives: Behavioral: Dietary sodium restriction |
| Usual diet | No intervention | Usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from day 14 to day 28
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: from day 14 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start3 Jan 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sodium ImbalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesper Norgaard Bech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jesper Norgaard Bech, Regional Hospital Holstebro
- Investigators
- Bodil Hornstrup, Principal investigator, M.D., Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022133
- Sponsor's protocol ID
- BGH-5-2017
- Other IDs
- 1-10-72-253-17
- Acronym
- ROSA
- Status last verified
- Aug 2023
- First submitted
- 23 Apr 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hornstrup BG, Hoffmann-Petersen N, Lauridsen TG, Bech JN. Dietary sodium restriction reduces blood pressure in patients with treatment resistant hypertension. BMC Nephrol. 2023 Sep 19;24(1):274. doi: 10.1186/s12882-023-03333-9.
PubMed 37726656
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
- ClinicalTrials.gov ID
- NCT06022133
- Acronym / sponsor ID
- ROSA / BGH-5-2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jesper Norgaard BechUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
| Arm | Type | Receives |
|---|---|---|
| Dietary sodium restriction | Experimental | Behavioral: Dietary sodium restrictionDIetary sodium restriction |
| Usual diet | No intervention | –Usual diet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary sodium restrictionSelfemployed dietary sodium restriction | Behavioural | Dietary sodium restriction |
Primary outcome
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)
5 secondary outcomes
Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)
Time frame: from day 14 to day 28
Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)
Time frame: from day 14 to day 28
Changes in day:night sodium urinary sodium excretion
Time frame: from day 14 to day 28
Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)
Time frame: from day 14 to day 28
Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)
Time frame: from day 14 to day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 37726656Hornstrup BG, Hoffmann-Petersen N, Lauridsen TG, Bech JN. Dietary sodium restriction reduces blood pressure in patients with treatment resistant hypertension. BMC Nephrol. 2023 Sep 19;24(1):274. doi: 10.1186/s12882-023-03333-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bodil Hornstrup principal investigator
M.D., Ph.D.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary sodium restriction in people with Sodium Imbalance and Nocturnal Blood Pressure, run by Jesper Norgaard Bech at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nocturnal systolic blood pressure (time frame: from day 14 to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06022133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.