Hypertension,EssentialVASANCT05165823
The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients
A study testing Sodium restriction in people with Hypertension,Essential, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Sodium restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2022to 26 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≤ 35 kg/m2
- Essential hypertension
- eGFR > 15 ml/min/1,73m2
- Albumine-to-creatinine-ratio < 500 mg/g
- Safe anticonception if women in childbearing age.
- Able to adhere to dietary regimen
Who cannot join
- Secondary hypertension
- Clinically significant heart failure (NYHA 3-4)
- Clinically significant liver disease
- Diabetes mellitus (type 1 and 2)
- Active cancer (except skin cancer)
- Renal transplant
Show all 12Show fewer
- Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
- Proliferative glomerulonephritis or ANCA-related disease
- Continuous immunosuppressant treatment
- Pregnancy or lactation
- Alcohol abuse
- If the investigator finds the participant unfit to complete the project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.
- Conditions
- Hypertension,Essential
- Being tested
- Sodium restriction
- Keywords
- Salt sensitivity, Sodium sensitivity, Salt restriction, Salt-blood test, Dietary intervention, Hypertension
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium restrictionBehavioural
Participants will be guided in minimizing sodium intake. Guidance will be both oral and written. Bread with low sodium content will be offered to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Sodium restriction | Experimental | Not described Receives: Behavioral: Sodium restriction |
| Usual diet | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic 24-hour blood pressure
Difference in systolic blood pressure measured before and after intervention
Measured: Measured before and after 4 weeks' intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start8 Feb 2022
- Primary completion5 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Lundgreen Duus, Regional Hospital Holstebro
- Investigators
- Camilla Lundgreen Duus, Principal investigator, University Clinic in Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165823
- Sponsor's protocol ID
- CLD-2-2021
- Acronym
- VASA
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duus CL, Nielsen SF, Hornstrup BG, Mose FH, Bech JN. Dietary Sodium Reduction Reveals Aldosterone Dysregulation in Patients With Essential Hypertension. J Clin Hypertens (Greenwich). 2026 Mar;28(3):e70229. doi: 10.1111/jch.70229.
PubMed 41761767Duus CL, Nielsen SF, Hornstrup BG, Mose FH, Bech JN. Self-Performed Dietary Sodium Reduction and Blood Pressure in Patients With Essential Hypertension: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Jun 18;13(12):e034632. doi: 10.1161/JAHA.124.034632. Epub 2024 Jun 6.
PubMed 38842286
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05165823
- Acronym / sponsor ID
- VASA / CLD-2-2021
- Conditions
- Hypertension,Essential
- Keywords
- Salt sensitivity, Sodium sensitivity, Salt restriction, Salt-blood test, Dietary intervention, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 21 Dec 2021 (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.
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium restriction | Experimental | Behavioral: Sodium restriction |
| Usual diet | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI ≤ 35 kg/m2
- Essential hypertension
- eGFR > 15 ml/min/1,73m2
- Albumine-to-creatinine-ratio < 500 mg/g
- Safe anticonception if women in childbearing age.
Key exclusion criteria (12 listed)
- Secondary hypertension
- Clinically significant heart failure (NYHA 3-4)
- Clinically significant liver disease
- Diabetes mellitus (type 1 and 2)
- Active cancer (except skin cancer)
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 |
|---|---|---|
| Sodium restrictionParticipants will be guided in minimizing sodium intake. Guidance will be both oral and written. Bread with low sodium content will be offered to the participants. | Behavioural | Sodium restriction |
Primary outcome
Change in systolic 24-hour blood pressure
Time frame: Measured before and after 4 weeks' intervention
Difference in systolic blood pressure measured before and after intervention
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 22 Sep 2023.
- Derived from this study: PubMed 41761767Duus CL, Nielsen SF, Hornstrup BG, Mose FH, Bech JN. Dietary Sodium Reduction Reveals Aldosterone Dysregulation in Patients With Essential Hypertension. J Clin Hypertens (Greenwich). 2026 Mar;28(3):e70229. doi: 10.1111/jch.70229.
- Derived from this study: PubMed 38842286Duus CL, Nielsen SF, Hornstrup BG, Mose FH, Bech JN. Self-Performed Dietary Sodium Reduction and Blood Pressure in Patients With Essential Hypertension: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Jun 18;13(12):e034632. doi: 10.1161/JAHA.124.034632. Epub 2024 Jun 6.
- 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.
Camilla Lundgreen Duus principal investigator
University Clinic in Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium restriction in people with Hypertension,Essential, run by Regional Hospital Holstebro at 1 site 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 6 inclusion and 12 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 22 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 1 site 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?
Change in systolic 24-hour blood pressure (time frame: Measured before and after 4 weeks' intervention). 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 NCT05165823, which also lists 2 linked publications.
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 22 Sep 2023.