Central Blood Pressure

November 27, 2017 updated by: Laura Vricella, MD, St. Louis University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women > or equal to 14 year old to 60 years old

Description

Inclusion Criteria:

  • ≤20 weeks pregnant

Exclusion Criteria:

  • Multi-pregnancy; Fetal anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse wave analysis
Time Frame: 1 year
pulse wave analysis can be a predictor of gestational hypertension/preeclampsia.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Laura Vricella, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

July 11, 2017

Study Completion (Actual)

July 11, 2017

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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