Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass

NCT ID: NCT01278732

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-03-31

Brief Summary

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The investigators aim to investigate whether central systolic blood pressure, as measured during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of left ventricular mass than peripheral systolic blood pressure during ABPM.

Detailed Description

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It seems obvious that central blood pressures are pathophysiologically more relevant than peripheral blood pressures for the pathogenesis of cardiovascular disease: it is central systolic pressure (cSBP) against the heart ejects (afterload), and it is central pulse pressure (cPP) that distends the large elastic arteries. Indeed, cSBP and cPP have been associated more closely with left ventricular hypertrophy and carotid atherosclerosis as markers of hypertensive end-organ damage than brachial pressures in various populations. However, in these studies office blood pressure measurements have been used. As ABPM measurements per se show a closer association with hypertensive end-organ damage than office measurements, and as the investigators have recently developed and validated a novel algorithm (ARCSolver) to calculate central blood pressures from peripheral waveforms, the investigators speculate that cSBP measured during ABPM may be the best predictor of left ventricular mass.

Conditions

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Suspected Arterial Hypertension

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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untreated persons with suspected hypertension

no intervention performed

Intervention Type OTHER

no intervention is performed

Interventions

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no intervention performed

no intervention is performed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\> 18 years of age,

* no intake of antihypertensive medications
* should have an indication for ABPM (suspected arterial hypertension)

Exclusion Criteria

* no written informed consent
* left ventricular hypertrophy due to other reasons than hypertension (hypertrophic cardiomyopathy, infiltrative cardiomyopathy, valvular heart disease, congenital heart disease)
* inability to provide adequate echocardiographic readings
* segmental contraction abnormalities of the left ventricle
* contraindications for ABPM (lymphedema both arms)
* other rhythm than stable sinus rhythm
* unstable clinical condition, including recent severe infections
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Austrian Society of Hypertension

UNKNOWN

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

I.E.M. (Stolberg, Germany)

UNKNOWN

Sponsor Role collaborator

Klinikum Wels-Grieskirchen

OTHER

Sponsor Role lead

Responsible Party

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Thomas Weber

PD Dr. Thomas Weber

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Weber, MD, associate professor

Role: PRINCIPAL_INVESTIGATOR

Cardiology Department, Klinikum Wels-Grieskirchen, Austria

Locations

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Cardiology Department, Klinikum Wels-Grieskirchen

Wels, Upper Austria, Austria

Site Status

Cardiology Department, University of Graz

Graz, , Austria

Site Status

Cardiology Department, University of Lübeck

Lübeck, , Germany

Site Status

Sotiria Hospital 3rd Department of Internal Medicine

Athens, , Greece

Site Status

Department of Medical and Surgical Sciences, University of Brescia

Brescia, , Italy

Site Status

Clinica Medica, Hospitalo San Gerardo

Monza, , Italy

Site Status

Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia

Perugia, , Italy

Site Status

Hospital de Sagunto

Port de Sagunt, , Spain

Site Status

University of Basel

Basel, , Switzerland

Site Status

Clinical pharmacology unit, University of Cambridge

Cambridge, , United Kingdom

Site Status

Countries

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Austria Germany Greece Italy Spain Switzerland United Kingdom

References

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Weber T, Wassertheurer S, Schmidt-Trucksass A, Rodilla E, Ablasser C, Jankowski P, Lorenza Muiesan M, Giannattasio C, Mang C, Wilkinson I, Kellermair J, Hametner B, Pascual JM, Zweiker R, Czarnecka D, Paini A, Salvetti M, Maloberti A, McEniery C. Relationship Between 24-Hour Ambulatory Central Systolic Blood Pressure and Left Ventricular Mass: A Prospective Multicenter Study. Hypertension. 2017 Dec;70(6):1157-1164. doi: 10.1161/HYPERTENSIONAHA.117.09917. Epub 2017 Oct 23.

Reference Type DERIVED
PMID: 29061725 (View on PubMed)

Other Identifiers

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EK D-4-10

Identifier Type: -

Identifier Source: org_study_id

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