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

This study is currently recruiting participants.
Verified November 2013 by Klinikum Wels-Grieskirchen
Sponsor:
Collaborators:
Austrian Society of Hypertension (Werner Klein Stipendium)
Government of lower Austria and European Funds for Regional Development (WST3-T-81/015-2008)
I.E.M. (Stolberg, Germany) - unrestricted grant
Information provided by (Responsible Party):
Thomas Weber, Klinikum Wels-Grieskirchen
ClinicalTrials.gov Identifier:
NCT01278732
First received: January 18, 2011
Last updated: November 16, 2013
Last verified: November 2013
  Purpose

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 Intervention
Suspected Arterial Hypertension
Other: no intervention performed

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mas

Resource links provided by NLM:


Further study details as provided by Klinikum Wels-Grieskirchen:

Primary Outcome Measures:
  • Left ventricular mass (m-mode echocardiography) [ Time Frame: measured within 4 weeks from ABPM ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urine albumine / creatinine ratio [ Time Frame: measured within 2 weeks from ABPM but before antihypertensive treatment is started ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
untreated persons with suspected hypertension Other: no intervention performed
no intervention is 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278732

Contacts
Contact: Thomas Weber, MD, Associate Prof. 0043 7242 415 2215 thomas.weber3@liwest.at

Locations
Austria
Cardiology Department, Klinikum Wels-Grieskirchen Recruiting
Wels, Upper Austria, Austria, 4600
Contact: Thomas Weber    0043 7242 415 2215    thomas.weber3@liwest.at   
Principal Investigator: Thomas Weber, MD, Associate Prof.         
Cardiology Department, University of Graz Recruiting
Graz, Austria
Contact: Robert Zweiker, MD Professor       Zweiker Robert <robert.zweiker@medunigraz.at>   
Principal Investigator: Robert Zweiker, MD Professor         
Germany
Cardiology Department, University of Lübeck Not yet recruiting
Lübeck, Germany
Contact: Kai Mortensen, MD       Kai Mortensen <kaimortensen@yahoo.de>   
Principal Investigator: Kai Mortensen, MD         
Sub-Investigator: Johannes Baulmann, MD         
Greece
Sotiria Hospital 3rd Department of Internal Medicine Recruiting
Athens, Greece
Contact: Athanase Protogerou, MD       Athanase Protogerou <athanprot@gmail.com>   
Principal Investigator: Athanase Protogerou, MD         
Italy
Department of Medical and Surgical Sciences, University of Brescia Recruiting
Brescia, Italy
Contact: Maria Lorenza Muiesan, MD Associate Professor       Maria Lorenza Muiesan <muiesan@med.unibs.it>   
Principal Investigator: Maria Lorenza Muiesan, MD Associate Professor         
Clinica Medica, Hospitalo San Gerardo Recruiting
Monza, Italy
Contact: Cristina Giannatasio, MD Associate professor       Cristina Giannattasio <cristina.giannattasio@unimib.it>   
Principal Investigator: Cristina Giannatasio, MD associate professor         
Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia Recruiting
Perugia, Italy
Contact: Giuseppe Schillaci, MD Associate Professor       Giuseppe Schillaci <skill@unipg.it>   
Principal Investigator: Giuseppe Schillaci, MD Associate Professor         
Spain
Hospital de Sagunto Recruiting
Puerto de Sagunto, Spain, E - 46520
Contact: Enrique Rodillo Sala, MD    +34962659400    rodilla_enr@gva.es   
Principal Investigator: Enrique Rodillo Sala, MD         
Switzerland
University of Basel Not yet recruiting
Basel, Switzerland
Contact: Arno Schmidt-Trucksäss, MD Professor       Arno Schmidt-Trucksäss <arno.schmidt-trucksaess@unibas.ch>   
Principal Investigator: Arno Schmidt-Trucksäss, MD Professor         
United Kingdom
Clinical pharmacology unit, University of Cambridge Recruiting
Cambridge, United Kingdom
Contact: Carmel McEniery, MD PhD       Carmel McEniery <cmm41@cam.ac.uk>   
Sub-Investigator: Carmel McEniery, MD PhD         
Principal Investigator: Ian Wilkinson, MD PhD         
Sponsors and Collaborators
Klinikum Wels-Grieskirchen
Austrian Society of Hypertension (Werner Klein Stipendium)
Government of lower Austria and European Funds for Regional Development (WST3-T-81/015-2008)
I.E.M. (Stolberg, Germany) - unrestricted grant
Investigators
Principal Investigator: Thomas Weber, MD, associate professor Cardiology Department, Klinikum Wels-Grieskirchen, Austria
  More Information

No publications provided

Responsible Party: Thomas Weber, PD Dr. Thomas Weber, Klinikum Wels-Grieskirchen
ClinicalTrials.gov Identifier: NCT01278732     History of Changes
Other Study ID Numbers: EK D-4-10
Study First Received: January 18, 2011
Last Updated: November 16, 2013
Health Authority: Austria: Federal Ministry for Health

Keywords provided by Klinikum Wels-Grieskirchen:
arterial hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014