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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

Central Hemodynamic and Sodium Urinary

Clinicaltrials.gov identifier NCT03932422

Recruitment Status Active, not recruiting

First Posted April 30, 2019

Last update posted August 3, 2020

Study Description

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.

  • Condition or Disease:Hypertension
  • Intervention/Treatment: Diagnostic Test: Evaluate if the individuals are resistant hypertensive patients
  • Phase: N/A
Detailed 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).

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 100 participants
  • Observational Model: Case-Control
  • Time Perspective: Cross-Sectional
  • Official Title: Analysis of Central Hemodynamic Parameters and Sodium Urinary Excretion in Controlled and Resistant Hypertensive Patients
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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
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.
Outcome Measures
  • Primary Outcome Measures: 1. Pulse wave velocity [ Time Frame: 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. ]
    The investigators has the objective of investigating if the urinary sodium quantity is associated with pulse wave velocity in resistant hypertensive individuals.
  • 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

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
Criteria

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.

Contacts and Locations
Contacts
Locations

Brazil, São Paulo
Fundação Faculdade Regional de Medicina (FUNFARME)
São José do Rio Preto

Sponsors and Collaborators

Hospital de Base

Sao Jose do Rio Preto Medical School

Investigators

Principal Investigator: José F Vilela-Martin, MD PhD FAHA State Medical School at São José do Rio Preto (FAMERP), São Paulo, Brazil

More Information
  • Responsible Party: Hospital de Base
  • ClinicalTrials.gov Identifier: NCT03932422 History of Changes
  • Other Study ID Numbers: CHASSI
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: August 3, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Hospital de Base: hypertension
    resistant hypertension
    arterial stiffness
    sodium urine test
  • Additional relevant MeSH terms: Hypertension