HypertensionNCT03026010
Central Blood Pressure
An observational study of Hypertension, run by St. Louis University.
Trial summary
The aim of the study is to check standard screening blood pressure in the arm and central blood pressure, the blood pressure at the heart in pregnant women. The standard brachial pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to distinguish preeclampsia from other types of… Read more about this study
- Who is it for?
- Ages 14 to 60 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- central blood pressure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 11 Jul 2017
- 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 14 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant women > or equal to 14 year old to 60 years old
Who may be able to join
- ≤20 weeks pregnant
Who cannot join
- Multi-pregnancy; Fetal anomalies
About this study
Official title: Early Detection of Central Blood Pressure and Arterial Stiffness (Pulse Wave Analysis) Can be a Predictor of Gestational Hypertension/Preeclampsia.
The aim of the study is to check standard screening blood pressure in the arm and central blood pressure, the blood pressure at the heart in pregnant women. The standard brachial pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those at risk. Central aortic pressure monitoring has become a valuable clinical tool and preliminary studies suggest that measuring of central blood pressure may be better predictor of preeclampsia. It is non invasive and doesn't require undressing. It involves using a standard blood pressure cuff placed around the thigh, checking carotid pulse and pressure with an ultrasound and taking measurements of the person neck to torso. With this knowledge it will be a useful screening tool to identify these patients at higher risk and hopefully lead to closer monitoring, earlier treatment and reduced morbidity and mortality
Read the detailed description
When blood pressure is measured conventionally over the brachial artery it is assumed that these measurements accurately reflect pressures in the central circulation. However, central aortic pressure is the blood pressure at the root of aorta and are determined not only by cardiac output and peripheral vascular resistance, but by the stiffness of conduit arteries and the timing and magnitude of pressure wave reflection.
Studies have shown the importance of central aortic pressure and its implications in assessing the efficacy of antihypertensive treatment with respect to cardiovascular risk factors. In the CAFE Study the traditional method of measuring blood pressure in the arms has been shown to underestimate the efficacy of drugs such as amlodipine and overestimate the efficacy of those like atenolol (4). This clinical trial demonstrated that different medications for lowering blood pressure have different effects on the central aortic pressure and blood flow characteristics, despite producing similar brachial blood pressure readings. They also were able to show that central aortic pressures are a better independent predictor of cardiovascular and renal outcome. The Strong Heart Study went further to depict how central pressure are more predictive of the load imposed on the coronary and cerebral arteries and thereby bear a stronger relationship to vascular damage and prognosis.
Hypertensive disorders of pregnancy, in particular, preeclampsia, are a leading cause of maternal and neonatal morbidity and mortality. In the United States and the United Kingdom, approximately 5% of pregnancies are complicated by preeclampsia, and of these patients, 1-2% progress to eclampsia. It is estimated that these rates are higher in developing countries. An estimated 50,000 women die annually from preeclampsia worldwide. The presence of hypertension during pregnancy is also associated with a two-fold increase in the risk of gestational diabetes mellitus. In addition, a history of preeclampsia increases a women's subsequent risk of vascular disease, including hypertension, ischemic heart disease, myocardial infarction and stroke. The increased risk of complications is not limited to the mother; babies of women with hypertensive disorders during pregnancy are more likely to suffer adverse outcomes than those of women without hypertension. A large cross-sectional study observing more than 250,000 women and their infants showed that women with gestational hypertension were at a 30% greater risk of death or major morbidity, and women with pre-eclampsia had a 400% increased risk, compared to women without hypertension. Although preeclampsia is not preventable, early diagnosis, careful monitoring and aggressive treatment is crucial in preventing mortality.
The brachial pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those at risk. Central aortic pressure monitoring has become a valuable clinical tool outside of pregnancy, particular in assessment of patient's hypertension, renal disease and diabetes. Preliminary studies suggest that measuring of central blood pressure may be predictive preeclampsia. In normal pregnancy aortic stiffness has been shown to vary throughout the pregnancy, reaching its lowest point in second trimester and rising again in the third trimester. A number of studies have investigated the change in pulse wave indices in the third trimester across the spectrum of hypertensive disorders. Central pressures, along with Augmentation pressure were found to be significantly higher in gestational hypertension and preeclampsia compared to normal pregnancy. In addition, Aortic augmentation pressure and pulse wave velocity has been shown to vary between preeclampsia, gestational hypertension, and normal pregnancy. The ability to accurately identify women at risk for preeclampsia would have significant clinical benefits. The ability to distinguish between hypertensive disorders and identify those women who have increased risk of preeclampsia can lead to better management of hypertensive disorders during pregnancy and therefore better outcomes for both mother and child. The aim of our study is to examine if early evaluation of central blood pressure and arterial stiffness (pulse wave analysis) can be a predictor of gestational hypertension/preeclampsia.
- Conditions
- Hypertension
- Being tested
- central blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central blood pressureProcedure or surgery
SphygmoCor XCEL will be used to measure both standard blood pressure in the arm and central pressure, the blood pressure at the heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse wave analysis
pulse wave analysis can be a predictor of gestational hypertension/preeclampsia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2016
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Vricella, MD, St. Louis University
- Investigators
- Laura Vricella, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026010
- Sponsor's protocol ID
- 23621
- Status last verified
- Nov 2017
- First submitted
- 12 Jan 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Central Blood Pressure and Arterial Stiffness (Pulse Wave Analysis) Can be a Predictor of Gestational Hypertension/Preeclampsia.
- ClinicalTrials.gov ID
- NCT03026010
- Acronym / sponsor ID
- 23621
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 20 Jan 2017 (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.
The aim of the study is to check standard screening blood pressure in the arm and central blood pressure, the blood pressure at the heart in pregnant women. The standard brachial pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those at risk. Central aortic pressure monitoring has become a valuable clinical tool and preliminary studies suggest that measuring of central blood pressure may be better predictor of preeclampsia. It is non invasive and doesn't require undressing. It involves using a standard blood pressure cuff placed around the thigh, checking carotid pulse and pressure with an ultrasound and taking measurements of the person neck to torso. With this knowledge it will be a useful screening tool to identify these patients at higher risk and hopefully lead to closer monitoring, earlier treatment and reduced morbidity and mortality
Detailed description
When blood pressure is measured conventionally over the brachial artery it is assumed that these measurements accurately reflect pressures in the central circulation. However, central aortic pressure is the blood pressure at the root of aorta and are determined not only by cardiac output and peripheral vascular resistance, but by the stiffness of conduit arteries and the timing and magnitude of pressure wave reflection.
Studies have shown the importance of central aortic pressure and its implications in assessing the efficacy of antihypertensive treatment with respect to cardiovascular risk factors. In the CAFE Study the traditional method of measuring blood pressure in the arms has been shown to underestimate the efficacy of drugs such as amlodipine and overestimate the efficacy of those like atenolol (4). This clinical trial demonstrated that different medications for lowering blood pressure have different effects on the central aortic pressure and blood flow characteristics, despite producing similar brachial blood pressure readings. They also were able to show that central aortic pressures are a better independent predictor of cardiovascular and renal outcome. The Strong Heart Study went further to depict how central pressure are more predictive of the load imposed on the coronary and cerebral arteries and thereby bear a stronger relationship to vascular damage and prognosis.
Hypertensive disorders of pregnancy, in particular, preeclampsia, are a leading cause of maternal and neonatal morbidity and mortality. In the United States and the United Kingdom, approximately 5% of pregnancies are complicated by preeclampsia, and of these patients, 1-2% progress to eclampsia. It is estimated that these rates are higher in developing countries. An estimated 50,000 women die annually from preeclampsia worldwide. The presence of hypertension during pregnancy is also associated with a two-fold increase in the risk of gestational diabetes mellitus. In addition, a history of preeclampsia increases a women's subsequent risk of vascular disease, including hypertension, ischemic heart disease, myocardial infarction and stroke. The increased risk of complications is not limited to the mother; babies of women with hypertensive disorders during pregnancy are more likely to suffer adverse outcomes than those of women without hypertension. A large cross-sectional study observing more than 250,000 women and their infants showed that women with gestational hypertension were at a 30% greater risk of death or major morbidity, and women with pre-eclampsia had a 400% increased risk, compared to women without hypertension. Although preeclampsia is not preventable, early diagnosis, careful monitoring and aggressive treatment is crucial in preventing mortality.
The brachial pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those at risk. Central aortic pressure monitoring has become a valuable clinical tool outside of pregnancy, particular in assessment of patient's hypertension, renal disease and diabetes. Preliminary studies suggest that measuring of central blood pressure may be predictive preeclampsia. In normal pregnancy aortic stiffness has been shown to vary throughout the pregnancy, reaching its lowest point in second trimester and rising again in the third trimester. A number of studies have investigated the change in pulse wave indices in the third trimester across the spectrum of hypertensive disorders. Central pressures, along with Augmentation pressure were found to be significantly higher in gestational hypertension and preeclampsia compared to normal pregnancy. In addition, Aortic augmentation pressure and pulse wave velocity has been shown to vary between preeclampsia, gestational hypertension, and normal pregnancy. The ability to accurately identify women at risk for preeclampsia would have significant clinical benefits. The ability to distinguish between hypertensive disorders and identify those women who have increased risk of preeclampsia can lead to better management of hypertensive disorders during pregnancy and therefore better outcomes for both mother and child. The aim of our study is to examine if early evaluation of central blood pressure and arterial stiffness (pulse wave analysis) can be a predictor of gestational hypertension/preeclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women > or equal to 14 year old to 60 years old
Key inclusion criteria (1 listed)
- ≤20 weeks pregnant
Key exclusion criteria (1 listed)
- Multi-pregnancy; Fetal anomalies
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 |
|---|---|---|
| central blood pressureSphygmoCor XCEL will be used to measure both standard blood pressure in the arm and central pressure, the blood pressure at the heart. | Procedure or surgery | – |
Primary outcome
pulse wave analysis
Time frame: 1 year
pulse wave analysis can be a predictor of gestational hypertension/preeclampsia.
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 29 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Laura Vricella, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by St. Louis University.
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 1 inclusion and 1 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
pulse wave analysis (time frame: 1 year). 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 29 Nov 2017.