Suspected Arterial HypertensionNCT01278732
Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass
An observational study of Suspected Arterial Hypertension, run by Klinikum Wels-Grieskirchen at 10 sites in 7 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suspected Arterial Hypertension
- How many people
- 350 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Jan 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- > 18 years of age,
- no intake of antihypertensive medications
- should have an indication for ABPM (suspected arterial hypertension)
Who cannot join
- 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
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Italy3 sites
Department of Medical and Surgical Sciences, University of Brescia
Brescia
Clinica Medica, Hospitalo San Gerardo
Monza
Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia
Perugia
Austria2 sites
Cardiology Department, University of Graz
Graz
Cardiology Department, Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600
United Kingdom1 site
Clinical pharmacology unit, University of Cambridge
Cambridge
About this study
Official title: 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.
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.
- Conditions
- Suspected Arterial Hypertension
- Being tested
- no intervention performed
- Keywords
- arterial hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention performedOther
no intervention is performed
| Study group | Role | What they receive |
|---|---|---|
| untreated persons with suspected hypertension | Not described Receives: Other: no intervention performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass (m-mode echocardiography)
Measured: measured within 4 weeks from ABPM
Secondary outcomes (1)
urine albumine / creatinine ratio
Measured: measured within 2 weeks from ABPM but before antihypertensive treatment is started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suspected Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Wels-Grieskirchen
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Society of Hypertension, European Regional Development Fund, I.E.M. (Stolberg, Germany)
- Responsible party
- Principal investigator, Thomas Weber, Klinikum Wels-Grieskirchen
- Investigators
- Thomas Weber, MD, associate professor, Principal investigator, Cardiology Department, Klinikum Wels-Grieskirchen, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278732
- Sponsor's protocol ID
- EK D-4-10
- Status last verified
- Mar 2015
- First submitted
- 18 Jan 2011
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mas
- ClinicalTrials.gov ID
- NCT01278732
- Acronym / sponsor ID
- EK D-4-10
- Conditions
- Suspected Arterial Hypertension
- Keywords
- arterial hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Klinikum Wels-GrieskirchenUniversity, hospital or other
- Collaborators
- Austrian Society of Hypertension, European Regional Development Fund, I.E.M. (Stolberg, Germany)
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| untreated persons with suspected hypertension | – | Other: no intervention performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (3 listed)
- > 18 years of age,
- no intake of antihypertensive medications
- should have an indication for ABPM (suspected arterial hypertension)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention performedno intervention is performed | Other | untreated persons with suspected hypertension |
Primary outcome
Left ventricular mass (m-mode echocardiography)
Time frame: measured within 4 weeks from ABPM
1 secondary outcome
urine albumine / creatinine ratio
Time frame: measured within 2 weeks from ABPM but before antihypertensive treatment is started
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 29061725Weber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Weber, MD, associate professor principal investigator
Cardiology Department, Klinikum Wels-Grieskirchen, Austria
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suspected Arterial Hypertension, run by Klinikum Wels-Grieskirchen at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Austria, Germany, Greece, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass (m-mode echocardiography) (time frame: measured within 4 weeks from ABPM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.