CClinicalTrials.gg
CompletedNCT01278732Updated Apr 3, 2015

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

An observational study in Suspected Arterial Hypertension, sponsored by Klinikum Wels-Grieskirchen. Completed at 10 sites in 7 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-03.

Sponsored by Klinikum Wels-Grieskirchen · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Suspected Arterial Hypertension

Browse trials for

Keywords

  • arterial hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 350 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Klinikum Wels-Grieskirchen is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

community sample

Inclusion criteria

> 18 years of age,

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

Exclusion criteria

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
05

Study design

Time perspective
Prospective
Enrollment
350 participants (actual)

Groups and cohorts

  • untreated persons with suspected hypertension

    Other: no intervention performed

Interventions

  • Otherno intervention performed

    no intervention is performed

06

What researchers measure

Primary outcomes

  1. Left ventricular mass (m-mode echocardiography)

    Time frame: measured within 4 weeks from ABPM

Secondary outcomes

  1. urine albumine / creatinine ratio

    Time frame: measured within 2 weeks from ABPM but before antihypertensive treatment is started

07

Study locations

10 sites
  • Cardiology Department, Klinikum Wels-Grieskirchen
    Wels, Upper Austria 4600, Austria
  • Cardiology Department, University of Graz
    Graz, Austria
  • Cardiology Department, University of Lübeck
    Lübeck, Germany
  • Sotiria Hospital 3rd Department of Internal Medicine
    Athens, Greece
  • Department of Medical and Surgical Sciences, University of Brescia
    Brescia, Italy
  • Clinica Medica, Hospitalo San Gerardo
    Monza, Italy
  • Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia
    Perugia, Italy
  • Hospital de Sagunto
    Puerto de Sagunto, E - 46520, Spain
  • University of Basel
    Basel, Switzerland
  • Clinical pharmacology unit, University of Cambridge
    Cambridge, United Kingdom
08

References and documents

Publications

  • 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. PubMed 29061725 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01278732
Lead sponsor
Klinikum Wels-Grieskirchen
Collaborators
Austrian Society of Hypertension, European Regional Development Fund, I.E.M. (Stolberg, Germany)
Responsible party
Thomas Weber (PD Dr. Thomas Weber, Klinikum Wels-Grieskirchen) — Principal investigator
First posted
Jan 19, 2011
Start date
Jan 2011
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Apr 3, 2015

Study contacts

Thomas Weber, MD, associate professor
principal investigator · Cardiology Department, Klinikum Wels-Grieskirchen, Austria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion