Arterial HypertensionIDI-HTA2020NCT04677322
TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA
An observational study of Arterial Hypertension and Sodium Urine, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial summary
Arterial hypertension is an independent vascular risk factor and a frequent reason for consultation in Primary Care. It generates high cardiovascular morbidity and mortality (stroke, heart disease, kidney failure and other diseases). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arterial Hypertension, Sodium Urine, Primary Care Center
- What is being tested?
- Adult patients diagnosed and treated for high blood pressure
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed and treated for high blood pressure
Who may be able to join
- Patients over 40 years old.
- Patients diagnosed with HTA (according to criteria ESC/ESH 2018) in a PA consultation or through MAP at the health center.
- In treatment with single, double or triple antihypertensive therapy.
- Patients with ST figures ≥140.
- Patients with TD numbers ≥90.
- Patients with stable antihypertensive treatment or without modifications in the treatment at least in the last month.
- Patients who commit to follow up the study.
- Patients who have given written informed consent.
Who cannot join
- Patients with decompensated heart failure
- Severe renal failure.
- Decompensated liver disease.
- Taking non-insulin antidiabetic
- Hypertension of pharmacological origin and other causes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OBSERVATIONAL STUDY TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET THROUGH THE MONITORING OF SODIUM IN URINE IN PATIENTS WITH HIGH BLOOD PRESSURE IN THE PRIMARY CARE SETTING
Arterial hypertension is an independent vascular risk factor and a frequent reason for consultation in Primary Care. It generates high cardiovascular morbidity and mortality (stroke, heart disease, kidney failure and other diseases). Moreover, given that it is a modifiable factor and that there are intervention and control measures that would lead to a significant reduction in cardiovascular incidence and morbimortality, it can be stated that ETS is a major public health problem.
The approach to this risk factor can be pharmacological and non-pharmacological. The non-pharmacological approach is based on lifestyle modification. Among the measures aimed at modifying lifestyles is the restriction of daily intake of sodium in the diet. Such restriction enhances the hypotensive effect of pharmacological treatment so that its application and intensification would delay the start of pharmacological therapy, as well as avoid the need to increase the dose of antihypertensive drugs or the number of drugs to be used for the control of hypertension.
In relation to salt intake in the Spanish population, the average is above the figures of less than 5 grams per day recommended by the WHO. Sodium intake can be estimated by determining the 24-hour urine sodium concentration. In addition, there is a positive correlation between systolic and diastolic blood pressure figures and the excretion of sodium in urine.
Read the detailed description
In the present work, with a prospective cohort observational study design, it intends to assess the effectiveness of the use of an educational program based on the follow up of a hyposodium diet and assessed through the routine use of urine sodium monitoring of the hypertensive patient in the primary care setting, in order to optimize treatment, as well as to review the clinical control in this group of patients. On the other hand, it is intended to establish guidelines in the form of practical guidelines to provide with a standardized clinical approach for primary care centers.
- Conditions
- Arterial Hypertension, Sodium Urine, Primary Care Center, Diet Habit
- Being tested
- Adult patients diagnosed and treated for high blood pressure
- Medical subject headings
- Hypertension, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult patients diagnosed and treated for high blood pressureDrug
Educational program interventions conducted by primary care staff to encourage adherence to a low-sodium diet consisting of direct action on the patient and provision of educational materials will be assessed. Compliance and follow-up of the low sodium diet will be done by monitoring the sodium in urine in the target population, selected according to the selection criteria described in the protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).
Measured: basal
Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).
Measured: 6 months
Secondary outcomes (4)
Sodium and potassium levels in 24-hour urine and isolated urine sample, with sodium limits of 20 mEq/L in a random urine sample and 40 to 220 mEq per day.
Measured: basal
Sodium and potassium levels in 24-hour urine and isolated urine sample, with sodium limits of 20 mEq/L in a random urine sample and 40 to 220 mEq per day, after educational intervention.
Measured: 6 months
To analyze the use of antihypertensive drugs USING morisk-green test, after educational intervention
Measured: 6 months
To verify compliance with the hyposodium diet and pharmacological treatment through the use of EuroQol-5D questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: the principal investigator withdraws from the project for personal reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677322
- Sponsor's protocol ID
- IDI-HTA-2020-01
- Acronym
- IDI-HTA2020
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVATIONAL STUDY TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET THROUGH THE MONITORING OF SODIUM IN URINE IN PATIENTS WITH HIGH BLOOD PRESSURE IN THE PRIMARY CARE SETTING
- ClinicalTrials.gov ID
- NCT04677322
- Acronym / sponsor ID
- IDI-HTA2020 / IDI-HTA-2020-01
- Conditions
- Arterial Hypertension, Sodium Urine, Primary Care Center, Diet Habit
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the principal investigator withdraws from the project for personal reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Dec 2020 (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.
Arterial hypertension is an independent vascular risk factor and a frequent reason for consultation in Primary Care. It generates high cardiovascular morbidity and mortality (stroke, heart disease, kidney failure and other diseases). Moreover, given that it is a modifiable factor and that there are intervention and control measures that would lead to a significant reduction in cardiovascular incidence and morbimortality, it can be stated that ETS is a major public health problem.
The approach to this risk factor can be pharmacological and non-pharmacological. The non-pharmacological approach is based on lifestyle modification. Among the measures aimed at modifying lifestyles is the restriction of daily intake of sodium in the diet. Such restriction enhances the hypotensive effect of pharmacological treatment so that its application and intensification would delay the start of pharmacological therapy, as well as avoid the need to increase the dose of antihypertensive drugs or the number of drugs to be used for the control of hypertension.
In relation to salt intake in the Spanish population, the average is above the figures of less than 5 grams per day recommended by the WHO. Sodium intake can be estimated by determining the 24-hour urine sodium concentration. In addition, there is a positive correlation between systolic and diastolic blood pressure figures and the excretion of sodium in urine.
Detailed description
In the present work, with a prospective cohort observational study design, it intends to assess the effectiveness of the use of an educational program based on the follow up of a hyposodium diet and assessed through the routine use of urine sodium monitoring of the hypertensive patient in the primary care setting, in order to optimize treatment, as well as to review the clinical control in this group of patients. On the other hand, it is intended to establish guidelines in the form of practical guidelines to provide with a standardized clinical approach for primary care centers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed and treated for high blood pressure
Key inclusion criteria (8 listed)
- Patients over 40 years old.
- Patients diagnosed with HTA (according to criteria ESC/ESH 2018) in a PA consultation or through MAP at the health center.
- In treatment with single, double or triple antihypertensive therapy.
- Patients with ST figures ≥140.
- Patients with TD numbers ≥90.
Key exclusion criteria (5 listed)
- Patients with decompensated heart failure
- Severe renal failure.
- Decompensated liver disease.
- Taking non-insulin antidiabetic
- Hypertension of pharmacological origin and other causes.
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 |
|---|---|---|
| Adult patients diagnosed and treated for high blood pressureEducational program interventions conducted by primary care staff to encourage adherence to a low-sodium diet consisting of direct action on the patient and provision of educational materials will be assessed. Compliance and follow-up of the low sodium diet will be done by monitoring the sodium in urine in the target population, selected according to the selection criteria described in the protocol. | Drug | – |
Primary outcome
Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).
Time frame: basal
Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).
Time frame: 6 months
4 secondary outcomes
Sodium and potassium levels in 24-hour urine and isolated urine sample, with sodium limits of 20 mEq/L in a random urine sample and 40 to 220 mEq per day.
Time frame: basal
Sodium and potassium levels in 24-hour urine and isolated urine sample, with sodium limits of 20 mEq/L in a random urine sample and 40 to 220 mEq per day, after educational intervention.
Time frame: 6 months
To analyze the use of antihypertensive drugs USING morisk-green test, after educational intervention
Time frame: 6 months
To verify compliance with the hyposodium diet and pharmacological treatment through the use of EuroQol-5D questionnaires
Time frame: 6 months
Results and safety
The study was stopped early (reason given: the principal investigator withdraws from the project for personal reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and Sodium Urine, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Mar 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 Spain. 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 was stopped early (reason given: the principal investigator withdraws from the project for personal reasons). Results are not available in the source record.
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?
Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic). (time frame: basal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.