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

Diet Habit Clinical Trial

— IDI-HTA2020  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04677322
• Other study ID #: IDI-HTA-2020-01
• Status: Terminated
• Start date: September 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2023
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with decompensated heart failure

• Severe renal failure.

• Decompensated liver disease.

• Taking non-insulin antidiabetic

• Hypertension of pharmacological origin and other causes.

Related Conditions & MeSH terms

• Arterial Hypertension
• Diet Habit
• Hypertension
• Primary Care Center

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro de salud Astillero	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).		basal
Primary	Systolic and diastolic TA values, the upper limit being 140 (systolic) and the lower range 90 (diastolic).		6 months
Secondary	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
Secondary	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
Secondary	To analyze the use of antihypertensive drugs USING morisk-green test, after educational intervention		6 months
Secondary	To verify compliance with the hyposodium diet and pharmacological treatment through the use of EuroQol-5D questionnaires		6 months