NCT04677322

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Adult patients diagnosed and treated for high blood pressure	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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-12-21
• Last updated: 2023-03-02

Locations

1 site across 1 country: Spain