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Central Blood Pressure

27 de noviembre de 2017 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Anticipado)

100

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años a 60 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

Inclusion Criteria:

  • ≤20 weeks pregnant

Exclusion Criteria:

  • Multi-pregnancy; Fetal anomalies

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pulse wave analysis
Periodo de tiempo: 1 year
pulse wave analysis can be a predictor of gestational hypertension/preeclampsia.
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Laura Vricella, MD, St. Louis University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2016

Finalización primaria (Actual)

11 de julio de 2017

Finalización del estudio (Actual)

11 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

12 de enero de 2017

Primero enviado que cumplió con los criterios de control de calidad

17 de enero de 2017

Publicado por primera vez (Estimar)

20 de enero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de noviembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

27 de noviembre de 2017

Última verificación

1 de noviembre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 23621

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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