Central Hemodynamic and Sodium Urinary

NCT ID: NCT03932422

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-03-15

Brief Summary

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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.

Detailed Description

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The urinary sodium (Na+) will be evaluated by flame photometry. Excretion of urinary sodium will be calculated by multiplying the urinary sodium concentration in mE /L by 24-hour urinary volume. Two to three urinary Na+ samples will be collected within six months.

3.3.3 ABLOOD PRESSURE MONITORING - 24 HOURS Ambulatorial blood pressure monitoring 24-hour will be performed using a Mobil-O-Graph® compact digital device (version 12, ambulatory pressure monitor, 2000, UK). Individuals will be instructed to maintain their normal activities of daily living. The device will be pre-programmed to measure blood pressure within 24 hours at 30-minute intervals every hour during the waking period and at 1-hour intervals during sleep. This device will evaluate the following parameters: systolic and peripheral diastolic blood pressure, mean arterial pressure, pulse pressure, systolic central aortic pressure, central diastolic aortic pressure (cDBP), central pulse pressure (cPP), augmentation index corrected for 75 bpm (AI75%) and pulse wave velocity (PWV).

Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

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.

Evaluate if the individuals are resistant hypertensive patients

Intervention Type 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.

Interventions

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Evaluate if the individuals are resistant hypertensive patients

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role collaborator

Hospital de Base

OTHER

Sponsor Role lead

Responsible Party

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JOSE FERNANDO VILELA-MARTIN

Principal Investigator and Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José F Vilela-Martin, MD PhD FAHA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Fundação Faculdade Regional de Medicina (FUNFARME)

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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José F Vilela-Martin, MD PhD FAHA

Role: CONTACT

+55 (17) 3201-5727

João M Menezes-Zanatta

Role: CONTACT

+55 (17) 996559618

Facility Contacts

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José F Vilela-Martin, MD PhD FAHA

Role: primary

+55 (17) 3201-5727

João M Menezes-Zanatta

Role: backup

+55 (17) 996559610

Other Identifiers

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CHASSI

Identifier Type: -

Identifier Source: org_study_id

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