Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass
This study is currently recruiting participants.
Verified October 2011 by Klinikum Wels-Grieskirchen
Sponsor:
Klinikum Wels-Grieskirchen
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: October 21, 2011
Last verified: October 2011
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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 |
| 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 | |
| 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 | |
| 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: | October 21, 2011 |
| 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 May 21, 2013