TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA

NCT04677322 | Terminated

• 1 other identifier: IDI-HTA-2020-01
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Arterial Hypertension; Sodium Urine; Primary Care Center; Diet Habit

Outcome Measures

Primary Outcomes (2)

• Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).

  basal

• Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).

  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.

  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.

  6 months

• To analyze the use of antihypertensive drugs USING morisk-green test, after educational intervention

  6 months

• To verify compliance with the hyposodium diet and pharmacological treatment through the use of EuroQol-5D questionnaires

  6 months

Interventions

Adult patients diagnosed and treated for high blood pressure DRUG

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed and treated for high blood pressure

You may qualify if:

• 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.

You may not qualify if:

• Patients with decompensated heart failure
• Severe renal failure.
• Decompensated liver disease.
• Taking non-insulin antidiabetic
• Hypertension of pharmacological origin and other causes.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (1)

Centro de salud Astillero

Santander, Cantabria, 39610, Spain

Location

MeSH Terms

Conditions

Hypertension; Feeding Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 21, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

ES (1)