Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Central Blood Pressure

27. November 2017 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

100

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

14 Jahre bis 60 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

Inclusion Criteria:

  • ≤20 weeks pregnant

Exclusion Criteria:

  • Multi-pregnancy; Fetal anomalies

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
pulse wave analysis
Zeitfenster: 1 year
pulse wave analysis can be a predictor of gestational hypertension/preeclampsia.
1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Laura Vricella, MD, St. Louis University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2016

Primärer Abschluss (Tatsächlich)

11. Juli 2017

Studienabschluss (Tatsächlich)

11. Juli 2017

Studienanmeldedaten

Zuerst eingereicht

12. Januar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Januar 2017

Zuerst gepostet (Schätzen)

20. Januar 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. November 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. November 2017

Zuletzt verifiziert

1. November 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 23621

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Hypertonie

Klinische Studien zur central blood pressure

3
Abonnieren