- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278732
Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass
March 31, 2015 updated by: Thomas Weber, Klinikum Wels-Grieskirchen
Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mas
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria
- Cardiology Department, University of Graz
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Upper Austria
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Wels, Upper Austria, Austria, 4600
- Cardiology Department, Klinikum Wels-Grieskirchen
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Lübeck, Germany
- Cardiology Department, University of Lübeck
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Athens, Greece
- Sotiria Hospital 3rd Department of Internal Medicine
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Brescia, Italy
- Department of Medical and Surgical Sciences, University of Brescia
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Monza, Italy
- Clinica Medica, Hospitalo San Gerardo
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Perugia, Italy
- Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia
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Puerto de Sagunto, Spain, E - 46520
- Hospital de Sagunto
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Basel, Switzerland
- University of Basel
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Cambridge, United Kingdom
- Clinical pharmacology unit, University of Cambridge
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
community sample
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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untreated persons with suspected hypertension
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no intervention is performed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Left ventricular mass (m-mode echocardiography)
Time Frame: measured within 4 weeks from ABPM
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measured within 4 weeks from ABPM
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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urine albumine / creatinine ratio
Time Frame: measured within 2 weeks from ABPM but before antihypertensive treatment is started
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measured within 2 weeks from ABPM but before antihypertensive treatment is started
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Weber, MD, associate professor, Cardiology Department, Klinikum Wels-Grieskirchen, Austria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
March 31, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK D-4-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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