Central Hemodynamic and Sodium Urinary

NCT03932422 | Unknown

• 1 other identifier: CHASSI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic arterial hypertension is one of major risk factors to development of target organ damage that culminate in cardiovascular diseases such as acute myocardial infarction and stroke. Sodium intake is related with elevation of arterial blood pressure due to rise of cardiac output and of arterial stiffness and it can be estimated by daily sodium excreted in urine 24h. Ambulatory Blood Pressure Monitoring can be used to obtain peripheral and central hemodynamic parameters \[arterial stiffness parameters - central blood pressure, pulse wave velocity and augmentation index\]. Applanation tonometry also can be used to check same central hemodynamic parameters. Both methods provide us important informations about the patients clinical conditions and help us to infer their prognosis. Therefore, this protocol aims measure the central hemodynamic parameters in hypertensive patients, controlled or resistant, and evaluate their sodium urinary excretion. The hypothesis is the resistant hypertensive patients have parameters higher than controlled hypertensive patients.

Conditions

Hypertension

Keywords

hypertension; resistant hypertension; arterial stiffness; sodium urine test

Outcome Measures

Primary Outcomes (1)

• Pulse wave velocity

  The investigators has the objective of investigating if the urinary sodium quantity is associated with pulse wave velocity in resistant hypertensive individuals.

  The urinary sodium excretion will be evaluated during 24 hours. This evaluation will be done by 2 to 3 times in a period of 6 months. Pulse wave velocity will be also evaluated in this period by the ambulatory blood pressure monitoring 24 hours.

Study Arms (2)

Controlled Hypertensive Patients (CHP)

Hypertensive patients that have blood pressure less than 140 x 90 mmHg. This parameter must be evaluated by ambulatory blood pressure monitoring

Resistant Hypertensive Patients (RHP)

Hypertensive patients that have blood pressure more than 140 x 90 mmHg and they use three antihypertensive medicines; or hypertensive patients that have blood pressure less than 140 x 90 mmHg, but they use four or more antihypertensive medicines. This parameter must be evaluated by ambulatory blood pressure monitoring.

Diagnostic Test: Evaluate if the individuals are resistant hypertensive patients

Interventions

Evaluate if the individuals are resistant hypertensive patients DIAGNOSTIC_TEST

Evaluation of the individuals has the objective determine if they are resistant hypertensive patients. This is important because the resistant people have worse prognosis than the controlled people and need more attention from the health professionals. Analysis must be done using the ambulatory blood pressure monitoring.

Resistant Hypertensive Patients (RHP)

Eligibility Criteria

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

Study Population

Individuals will be selected from the hypertensive patients who are assisted in the health service where the study will be performed.

You may qualify if:

• over than 18 years old;
• hypertensive patient for more than four weeks;
• controlled hypertension;
• resistant hypertension;
• regular patient in the local where the study will be done.

You may not qualify if:

• chronic renal failure in dyalisis;
• been in the hospital in last 60 days;
• used vasoactive drugs in last 30 days;
• heart failure in III or IV functional class (NYHA);
• pregnant/breastfeeding;
• serious liver disease;
• HIV positive;
• psychiatric diseases that make it difficult to participate;
• stroke or acute myocardial infarction in last 30 days;
• cancer with prognosis less than one year.

Sponsors & Collaborators

• Hospital de Base: lead
• Sao Jose do Rio Preto Medical School: collaborator

Study Sites (1)

Fundação Faculdade Regional de Medicina (FUNFARME)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biospecimens retained was urine to analyse the sodium urinary excretion during 24h. Must be done two collects and the data considered it will be the mean between both

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• José F Vilela-Martin, MD PhD FAHA

  State Medical School at São José do Rio Preto (FAMERP), São Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José F Vilela-Martin, MD PhD FAHA

CONTACT

+55 (17) 3201-5727; vilelamartin@uol.com.br

João M Menezes-Zanatta

CONTACT

+55 (17) 996559618; jm.zanatta@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Clinical Professor

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 30, 2019
• Study Start: July 15, 2019
• Primary Completion: February 15, 2021
• Study Completion: March 15, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

BR (1)