CompletedNot Applicable

The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients

Denmark72 participantsStarted 2022-02-08

Plain-language 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. Baseline measures will be done before intervention and outcome measures after the 4 weeks.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in systolic 24-hour blood pressure

Timeframe: Measured before and after 4 weeks' intervention

Trial details

NCT IDNCT05165823

SponsorRegional Hospital Holstebro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-05

View on ClinicalTrials.gov More Hypertension,Essential trials