HypertensionNCT01237717
Relationship of Urine Sodium Excretion to Central Blood Pressure and Aortic Pulse Wave Velocity
An observational study of Hypertension, run by DongGuk University at 1 site in South Korea.
Trial summary
One interesting area is the relationship of high salt intake and central aortic blood pressure. High salt intake is associated development of hypertension and cardiovascular mortality. Central aortic pressure is better correlated with cardiovascular events and mortality. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Dec 2011
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects with or without hypertension
Who may be able to join
- subjects without hypertension: n=100
- subjects with hypertension, not treated at least within 6months: n=100
Who cannot join
- secondary hypertension
- known diabetes (HbA1C >7.5%)
- night worker
- stage 3 hypertension
- renal artery stenosis
- primary aldosteronism
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- elevated GOT and/or glutamate-pyruvate transaminase > 2 fold of normal range
- heart failure, significant arrhythmia, angina, myocardial infarction, stroke, carotid stenosis
- pregnancy
- autoimmune disease, debilitating disease
- significant liver disease; active hepatitis, liver cirrhosis
- alcoholics
- Renal disease: Cr > 1.2 and/or proteinuria
- Medication affecting blood pressure and/or vascular stiffness, including lipid lowering agents
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang, Gyenggi, 410-773
About this study
One interesting area is the relationship of high salt intake and central aortic blood pressure. High salt intake is associated development of hypertension and cardiovascular mortality. Central aortic pressure is better correlated with cardiovascular events and mortality. With recent advances in technology, it is possible to measure central aortic pressure noninvasively and easily. Until now there is no study to evaluate the relationship of high salt intake and aortic blood pressure.
The purpose of the present study is to evaluate the relationship of high salt intake and aortic blood pressure and aortic stiffness.
Read more
Subjects with or without hypertension will be enrolled for investigation. Subjects with hypertension should be never treated with antihypertensive medications. Subjects with secondary hypertension, diabetes, heart failure, high grade kidney disease, ischemic heart disease, and major arrhythmia will be excluded.
Sodium intake is measured by 24 hour urinary sodium excretion, with the measurement of peripheral and central aortic blood pressure, and aortic pulse wave velocity.
Salt sensitive hypertension related single nucleotide polymorphism will be analyzed to define the relationship with high salt intake and aortic pressure and pulse wave velocity.
Read the detailed description
Measurements: should be performed for 2 days
- 24 hour urine Na, K and Creatinine, 24 hour urine amount
- Calculation of urine completeness index : Cr/(21 x Bwt)
- Definition of complete urine collection: complete index ≥ 0.7 and loss not more than one time and 100 mL
- Peripheral blood pressure (pBP)
- Microlife WatchBP Office
- Sitting position
- After 5 minutes resting
- Peripheral systolic BP (pSBP), Peripheral diastolic BP (pDBP),
- Central aortic blood pressure
- SphygmoCor (AtCor Medical, Australia)
- Central systolic blood pressure
- Difference between peripheral SBP and central SBP (SBPp-c)
- Pulse wave velocity
- VP2000 (Colin, Japan)
- Central pulse wave velocity: carotid-femoral Pulse Wave Velocity
- Measure by tape
- distance from suprasternal notch to carotid artery
- distance from suprasternal notch to femoral artery
- Silent environment
- Blood chemistry and complete blood count
- Measure at the morning of second day after overnight fasting
- complete blood count, blood urea nitrogen/Creatinine, fasting blood glucose, Total cholesterol, Triglyceride, High density lipoprotein cholesterol
- 24 hour ambulatory blood pressure measurement
Measurement protocol
- 1st day
- Visit hospital before 9:00 AM after overnight fasting
- start 24 hour urine collection from 9:00 AM (with education for complete collection)
- start 24 hour ambulatory blood pressure monitoring, in parallel with 24 hour urine collection
- 2nd day
- Measure central aortic blood pressure
- Measure blood Lab
- Measure Pulse Wave Velocity
Analysis of Salt sensitive gene polymorphism
- Single Base Extension technology(SBE)
- single nucleotide polymorphism rs2398162 and other salt sensitive hypertension related single nucleotide polymorphism
- Conditions
- Hypertension
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normotensive subjects | subjects without hypertension, and without diabetes, ischemic heart disease, major arrhythmia, heart failure, secondary hypertension, high grade renal disease, | |
| Hypertensive subjects | subjects with hypertension, 1. currently not treated at least within 6 months 2. without diabetes, ischemic heart disease, major arrhythmia, heart failure, secondary hypertension, high grade renal disease, |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relationship between 24 hour ambulatory blood pressure and 24 hour urine sodium/potassium excretion
the relationship between 24 hour ambulatory blood pressure and 24 hour urine sodium/potassium excretion will be analysed. daytime, nighttime and morning BP will be analysed to 24 hour urinary sodium/potassium excretion
Measured: cross-sectional study
Secondary outcomes (1)
the relationship between 24 hour urinary sodium/potassium excretion and central BP and arterial stiffness
Measured: Cross-sectional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Cardiology
- Responsible party
- Principal investigator, Moo-Yong Rhee, DongGuk University
- Investigators
- Moo-Yong Rhee, Prof,MD, PhD, Principal investigator, Cardiovascular Center, Dongguk University Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237717
- Sponsor's protocol ID
- 2010-1-15
- Status last verified
- Jan 2013
- First submitted
- 9 Nov 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Urine Sodium Excretion to Central Blood Pressure and Aortic Pulse Wave Velocity
- ClinicalTrials.gov ID
- NCT01237717
- Acronym / sponsor ID
- 2010-1-15
- Conditions
- Hypertension
- Keywords
- hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Collaborators
- The Korean Society of Cardiology
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Nov 2010 (estimated)
- 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.
One interesting area is the relationship of high salt intake and central aortic blood pressure. High salt intake is associated development of hypertension and cardiovascular mortality. Central aortic pressure is better correlated with cardiovascular events and mortality. With recent advances in technology, it is possible to measure central aortic pressure noninvasively and easily. Until now there is no study to evaluate the relationship of high salt intake and aortic blood pressure.
The purpose of the present study is to evaluate the relationship of high salt intake and aortic blood pressure and aortic stiffness.
Subjects with or without hypertension will be enrolled for investigation. Subjects with hypertension should be never treated with antihypertensive medications. Subjects with secondary hypertension, diabetes, heart failure, high grade kidney disease, ischemic heart disease, and major arrhythmia will be excluded.
Sodium intake is measured by 24 hour urinary sodium excretion, with the measurement of peripheral and central aortic blood pressure, and aortic pulse wave velocity.
Salt sensitive hypertension related single nucleotide polymorphism will be analyzed to define the relationship with high salt intake and aortic pressure and pulse wave velocity.
Detailed description
Measurements: should be performed for 2 days
- 24 hour urine Na, K and Creatinine, 24 hour urine amount
- Calculation of urine completeness index : Cr/(21 x Bwt)
- Definition of complete urine collection: complete index ≥ 0.7 and loss not more than one time and 100 mL
- Peripheral blood pressure (pBP)
- Microlife WatchBP Office
- Sitting position
- After 5 minutes resting
- Peripheral systolic BP (pSBP), Peripheral diastolic BP (pDBP),
- Central aortic blood pressure
- SphygmoCor (AtCor Medical, Australia)
- Central systolic blood pressure
- Difference between peripheral SBP and central SBP (SBPp-c)
- Pulse wave velocity
- VP2000 (Colin, Japan)
- Central pulse wave velocity: carotid-femoral Pulse Wave Velocity
- Measure by tape
- distance from suprasternal notch to carotid artery
- distance from suprasternal notch to femoral artery
- Silent environment
- Blood chemistry and complete blood count
- Measure at the morning of second day after overnight fasting
- complete blood count, blood urea nitrogen/Creatinine, fasting blood glucose, Total cholesterol, Triglyceride, High density lipoprotein cholesterol
- 24 hour ambulatory blood pressure measurement
Measurement protocol
- 1st day
- Visit hospital before 9:00 AM after overnight fasting
- start 24 hour urine collection from 9:00 AM (with education for complete collection)
- start 24 hour ambulatory blood pressure monitoring, in parallel with 24 hour urine collection
- 2nd day
- Measure central aortic blood pressure
- Measure blood Lab
- Measure Pulse Wave Velocity
Analysis of Salt sensitive gene polymorphism
- Single Base Extension technology(SBE)
- single nucleotide polymorphism rs2398162 and other salt sensitive hypertension related single nucleotide polymorphism
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normotensive subjects | – | –subjects without hypertension, and without diabetes, ischemic heart disease, major arrhythmia, heart failure, secondary hypertension, high grade renal disease, |
| Hypertensive subjects | – | –subjects with hypertension, 1. currently not treated at least within 6 months 2. without diabetes, ischemic heart disease, major arrhythmia, heart failure, secondary hypertension, high grade renal disease, |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with or without hypertension
Key inclusion criteria (2 listed)
- subjects without hypertension: n=100
- subjects with hypertension, not treated at least within 6months: n=100
Key exclusion criteria (14 listed)
- secondary hypertension
- known diabetes (HbA1C >7.5%)
- night worker
- stage 3 hypertension
- renal artery stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the relationship between 24 hour ambulatory blood pressure and 24 hour urine sodium/potassium excretion
Time frame: cross-sectional study
the relationship between 24 hour ambulatory blood pressure and 24 hour urine sodium/potassium excretion will be analysed. daytime, nighttime and morning BP will be analysed to 24 hour urinary sodium/potassium excretion
1 secondary outcome
the relationship between 24 hour urinary sodium/potassium excretion and central BP and arterial stiffness
Time frame: Cross-sectional study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
Moo-Yong Rhee, Prof,MD, PhD principal investigator
Cardiovascular Center, Dongguk University Ilsan Hospital
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 DongGuk University at 1 site in South Korea.
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 2 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jan 2013. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relationship between 24 hour ambulatory blood pressure and 24 hour urine sodium/potassium excretion (time frame: cross-sectional study). 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 23 Jan 2013.