HypertensionCHASSINCT03932422
Central Hemodynamic and Sodium Urinary
An observational study of Hypertension, run by Hospital de Base at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Evaluate if the individuals are resistant hypertensive patients
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2019to 15 Mar 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals will be selected from the hypertensive patients who are assisted in the health service where the study will be performed.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fundação Faculdade Regional de Medicina (FUNFARME)
São José do Rio Preto, São Paulo, 15090-000
José F Vilela-Martin, MD PhD FAHA, +55 (17) 3201-5727, vilelamartin@uol.com.br
João M Menezes-Zanatta, +55 (17) 996559610, jm.zanatta@gmail.com
About this study
Official title: Analysis of Central Hemodynamic Parameters and Sodium Urinary Excretion in Controlled and Resistant Hypertensive Patients
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.
Read the 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).
- Conditions
- Hypertension
- Being tested
- Evaluate if the individuals are resistant hypertensive patients
- Keywords
- hypertension, resistant hypertension, arterial stiffness, sodium urine test
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate if the individuals are resistant hypertensive patientsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Evaluate if the individuals are resistant hypertensive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start15 Jul 2019
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Collaborators
- Sao Jose do Rio Preto Medical School
- Responsible party
- Principal investigator, JOSE FERNANDO VILELA-MARTIN, Hospital de Base
- Investigators
- José F Vilela-Martin, MD PhD FAHA, Principal investigator, State Medical School at São José do Rio Preto (FAMERP), São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932422
- Sponsor's protocol ID
- CHASSI
- Acronym
- CHASSI
- Status last verified
- Feb 2021
- First submitted
- 13 Apr 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Central Hemodynamic Parameters and Sodium Urinary Excretion in Controlled and Resistant Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03932422
- Acronym / sponsor ID
- CHASSI / CHASSI
- Conditions
- Hypertension
- Keywords
- hypertension, resistant hypertension, arterial stiffness, sodium urine test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Collaborators
- Sao Jose do Rio Preto Medical School
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Diagnostic Test: Evaluate if the individuals are resistant hypertensive patientsHypertensive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals will be selected from the hypertensive patients who are assisted in the health service where the study will be performed.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate if the individuals are resistant hypertensive patientsEvaluation 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. | Diagnostic test | Resistant Hypertensive Patients (RHP) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José F Vilela-Martin, MD PhD FAHA principal investigator
State Medical School at São José do Rio Preto (FAMERP), São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Hospital de Base at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José F Vilela-Martin, MD PhD FAHA (+55 (17) 3201-5727, vilelamartin@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.