Central Hemodynamic and Sodium Urinary

Hypertension Clinical Trial

— CHASSI  

Official title:

Analysis of Central Hemodynamic Parameters and Sodium Urinary Excretion in Controlled and Resistant Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932422
• Other study ID #: CHASSI
• Status: Recruiting
• Start date: July 15, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: February 2021
• Source: Hospital de Base
• Contact: José F Vilela-Martin, MD PhD FAHA
• Phone: +55 (17) 3201-5727
• Email: vilelamartin[@]uol.com.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Brazil	Fundação Faculdade Regional de Medicina (FUNFARME)	São José do Rio Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Base	Sao Jose do Rio Preto Medical School

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.