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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278732
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : April 3, 2015
Austrian Society of Hypertension
European Regional Development Fund
I.E.M. (Stolberg, Germany)
Information provided by (Responsible Party):
Thomas Weber, Klinikum Wels-Grieskirchen

Brief 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.

Condition or disease Intervention/treatment
Suspected Arterial Hypertension Other: no intervention performed

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.

Study Type : Observational
Actual Enrollment : 350 participants
Time Perspective: Prospective
Official Title: Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mas
Study Start Date : January 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Group/Cohort Intervention/treatment
untreated persons with suspected hypertension Other: no intervention performed
no intervention is performed

Primary Outcome Measures :
  1. Left ventricular mass (m-mode echocardiography) [ Time Frame: measured within 4 weeks from ABPM ]

Secondary Outcome Measures :
  1. urine albumine / creatinine ratio [ Time Frame: measured within 2 weeks from ABPM but before antihypertensive treatment is started ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278732

Cardiology Department, Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
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, Spain, E - 46520
University of Basel
Basel, Switzerland
United Kingdom
Clinical pharmacology unit, University of Cambridge
Cambridge, United Kingdom
Sponsors and Collaborators
Klinikum Wels-Grieskirchen
Austrian Society of Hypertension
European Regional Development Fund
I.E.M. (Stolberg, Germany)
Principal Investigator: Thomas Weber, MD, associate professor Cardiology Department, Klinikum Wels-Grieskirchen, Austria

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Weber, PD Dr. Thomas Weber, Klinikum Wels-Grieskirchen Identifier: NCT01278732     History of Changes
Other Study ID Numbers: EK D-4-10
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015

Keywords provided by Thomas Weber, Klinikum Wels-Grieskirchen:
arterial hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases