Blood PressureBP-CONNCT04295434
Blood Pressure Control in ESH Excellence Centres
An observational study of Blood Pressure and Lifestyle Risk Reduction, run by Clinical Hospital Centre Zagreb at 46 sites in 22 countries.
Trial summary
In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Lifestyle Risk Reduction, White Coat Hypertension
- How many people
- 3,000 participants
- Where
- 46 sitesin 22 countries
- Study dates
- 1 Oct 2018to 1 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypertension that are under supervision of excellence centres participating in the study.
Who may be able to join
- Signed informed consent
Who cannot join
- Pregnancy and breastfeeding
- Terminal malignancy, reduced life expectancy (<6 months)
- Amputated limb
- Dementia
- Patients living in a nursing home
- Unsigned informed consent
Trial locations and contacts
46 sites in 22 countries.
46 sites in 22 countries
Greece10 sites, 10 recruiting
- Recruiting
Hypertension and Cardiovascular Prevention Clinic, 3rd Department of Medicine, Evangelismos Hospital
Athens, 10676
Emmanuel Andreadis, MD, andreadise@ath.forthnet.gr
- Recruiting
Hypertension Clinic, University Hospital Laiko
Athens, 11527
Dimitris P Papadopoulos, MD, jimpapdoc@yahoo.com
- Recruiting
University of Athens, Hippokration Hospital
Athens, 11527
Costas Tsioufis, Prof, MD, ktsioufis@gmail.com
- Recruiting
Hypertension Clinic, Department of Cardiology, KAT General Hospital
Athens, 14561
Charalampos Grassos, MD, harigrass@yahoo.gr
- Recruiting
Hypertension Clinic, Cardiology Department, Asklepeion Hospital
Athens
Athansios Manolis, Prof, MD, ajmanol@otenet.gr
- Recruiting
University Hospital of Heraklion
Heraklion, 71110
Ioannis Papadakis, MD, papadakisja@hotmail.com
Maria Marketou, MD, maryemarke@yahoo.gr
- Recruiting
Hypertension Center, Department of Nephrology, University Hospital of Ioannina
Ioannina, 45500
Rigas Kalaitzidis, MD, rigaska@gmail.com
- Recruiting
Hypertension Outpatient Clinic, 1st Propedeutic Dept. of Internal Medicine, AHEPA Hospital
Thessaloniki, 54636
Apostolos Hatzitolios, MD, axatzito@med.auth.gr
Pantelis Zebekakis, Prof, MD, pzebeka@med.auth.gr
- Recruiting
Hypertension Center, Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki
Thessaloniki, 54642
Pantelis Sarafidis, MD, psarafidis11@yahoo.gr
- Recruiting
Aristotle University of Thessaloniki, Papageorgiou General Hospital
Thessaloniki, 56403
Stella Douma, Prof, MD, sdouma@med.auth.gr
Germany5 sites, 5 recruiting
- Recruiting
Hypertension Center Berlin Charité
Berlin, 10117
Reinhold Kreutz, Prof, MD, reinhold.kreutz@charite.de
- Not yet recruiting
Hypertoniezentrum Bonn
Bonn, 53123
Rainer Düsing, MD, Prof, dusing@outlook.com
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Christian Beger, MD, Beger.Christian@mh-hannover.de
- Recruiting
Universitätskliniken des Saarlandes
Homburg, D-66421
Michael Böhm, MD, michael.boehm@uks.eu
- Recruiting
Hypertension Center Munich
Munich, 80333
Martin Middeke, MD, Prof, martin.middeke@gmx.de
Italy5 sites, 5 recruiting
- Not yet recruiting
Centre of Prevention and Treatment of Arterial Hypertension and Cardiovascular Risk Factors
Brescia
Enrico Agabiti Rosei, Prof, MD, enrico.agabitirosei@unibs.it
- Recruiting
S. Luca Hospital, Istituto Auxologico Italiano
Milan, 20149
Gianfranco Parati, Prof, MD, gianfranco.parati@unimib.it
Martino Pengo, MD, m.pengo@auxologico.it
- Recruiting
Ospedale Niguarda, Dip. De Gasperis e Università di Milano Bicocca
Milan, 20162
Cristina Giannattasio, Prof, MD, cristina.giannattasio@unimib.it
Alessandro Maloberti, MD, alessandro.maloberti@ospedaleniguarda.it
- Not yet recruiting
Napoli Hypertension Excellence Centre, Federico II Clinic Research Center for Hypertension and Related Conditions
Naples, 80131
Raffaele Izzo, Prof, MD, rafizzo@unina.it
- Not yet recruiting
Excellence Centre of Hypertension, Department of Medical Sciences, University of Torino
Torino, 10124
Franco Veglio, Prof, franco.veglio@unito.it
Belgium3 sites, 3 recruiting
- Recruiting
Erasmus Hospital
Brussels, 1070
Philippe Van de Borne, MD, Prof, philippe.van.de.borne@erasme.ulb.ac.be
- Recruiting
CHU de Liège
Liège, 4000
Jean-Marie Krzesinski, MD, Prof, jm.krzesinski@chu.ulg.ac.be
- Recruiting
Ambroise Paré University Hospital
Mons, 7000
Philippe Delmotte, MD, Philippe.Delmotte@hap.be
Czechia3 sites, 3 recruiting
- Recruiting
Charles University Medical School and University Hospital
Pilsen, 30599
Jan Filipovský, MD, Prof, filipovsky@fnplzen.cz
- Recruiting
Center for Hypertension, Charles University, Prague
Prague, 12808
Jiri Widimsky Jr., MD, Prof, jwidi@lf1.cuni.cz
- Recruiting
Institute for Clinical and Experimental Medicine (IKEM) and Thomayer Hospital, Prague
Prague, 14059
Renata Cifkova, MD, Prof, renata.cifkova@ftn.cz
Netherlands2 sites, 2 recruiting
- Not yet recruiting
University Hospital Maastricht
Maastricht, 6229 HX
Peter De Leeuw, Prof, MD, p.deleeuw@maastrichtuniversity.nl
- Not yet recruiting
Radboud University of Nijmegen Medical Center
Nijmegen, 6525 GA
Jacob Deinum, MD, j.deinum@aig.umcn.nl
Spain2 sites, 2 recruiting
- Not yet recruiting
Hipertensión Clinic, Internal Medicine, Hospital Clinico, University of Barcelona
Barcelona, 08036
Cristina Sierra, MD, PhD, csierra@clinic.cat
- Not yet recruiting
Hypertension Clinic, Nephrology Department, Reina Sofia University Hospital
Córdoba, 14004
Rafael Santamaría, MD, rsantamariao@gmail.com
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
St. Bartholomew's Royal London School of Medicine & Dentistry
London, E1 2AD
Melvin Lobo, MD PhD, m.d.lobo@qmul.ac.uk
- Not yet recruiting
The Pearl-Rose Clinic (Hypertension & Cardiovascular Risk), Hammersmith Hospital,
London, W12 0HS
Neil Chapman, MD, neil.chapman1@nhs.net
Armenia1 site, 1 recruiting
- Recruiting
Center of Preventive Cardiology, Yerevan
Yerevan, 0014
Parounak Zelveian, MD, zelveian@hotmail.com
Austria1 site, 1 recruiting
- Recruiting
Klinikum Wels-Grieskirchen
Wels, 4600
Thomas Weber, MD, thomas.weber3@liwest.at
Bulgaria1 site, 1 recruiting
- Recruiting
University Hospital "St. Anna"
Sofia, 1750
Dimitar Raev, Prof, draevbg56@yahoo.com
Croatia1 site, 1 recruiting
- Recruiting
University hospital centre Zagreb
Zagreb, City of Zagreb, 10000
Bojan Jelaković, MD, PhD, 00385959030751, jelakovicbojan@gmail.com
Estonia1 site, 1 recruiting
- Recruiting
Tallinn Hypertension Excellence Centre
Tallinn, 13419
Margus Viigimaa, Prof, MD, margus.viigimaa@regionaalhaigla.ee
Israel1 site, 1 recruiting
- Not yet recruiting
Assuta Ashdod University Hospital
Ashdod, 7747629
Adi Leiba, Prof, MD, drleiba@gmail.com
Lebanon1 site, 1 recruiting
- Not yet recruiting
American University Center, Hypertension/Vascular Medicine Division (Associated Centre)
Beirut
Abdel Berbari, MD, ab01@aub.edu.lb
Lithuania1 site, 1 recruiting
- Not yet recruiting
Kaunas Hypertension Excellence Centre
Kaunas, 47101
Rimvydas Slapikas, Prof, MD, rimvydas.slapikas@kmuk.lt
Poland1 site, 1 recruiting
- Not yet recruiting
Department of Internal Medicine, Hypertension and Vascular Diseases, Warsaw Medical University
Warsaw, 02-091
Zbigniew Gaciong, MD, zgaciong@hotmail.com
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar do Alto Ave, Minho University
Guimarães
Jorge Cotter, Prof, MD, jorgecotter@gmail.com
Romania1 site, 1 recruiting
- Recruiting
Department of Cardiology and Internal Medicine, Emergency Clinical Hospital of Bucharest
Bucharest
Maria Dorobantu, MD, maria.dorobantu@gmail.com
Serbia1 site, 1 recruiting
- Recruiting
Centre for Hypertension of the Clinical Centre of Serbia
Belgrade, 11000
Vesna Stojanov, MD, stojanovves@eunet.rs
Sweden1 site, 1 recruiting
- Not yet recruiting
Danderyd University Hospital
Stockholm, 182 57
Thomas Kahan, Prof, MD, thomas.kahan@sll.se
Ukraine1 site, 1 recruiting
- Not yet recruiting
National Scientific Center "The M.D. Strazhesko Institute of Cardiology"
Kyiv, 02000
Yuri Sirenko, MD, PhD, sirenkoyu@gmail.com
About this study
Official title: Study of the European Society of Hypertension on Blood Pressure Control in ESH Excellence Centres
In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres. The primary goals will be to determine the global, regional and country rates of hypertension control in Europe. Other goals will be to identify global and regional factors associated with blood pressure control in different European regions. The results obtained in the BP-CON-ESH project will be used to refine treatment strategies for improvement of blood pressure control and will serve as a basis for assessing future changes and trends in Europe.
Read the detailed description
The most important task of the European Society of Hypertension is to improve blood pressure treatment and increase blood pressure control, thus decreasing cardiovascular risk, premature cardiovascular and renal morbidity and mortality, with in addition a reduction of health-care costs. More than a decade ago, the European Society of Hypertension established a network of Excellence Centres. Those centres are leading institutions for the diagnosis and treatment of hypertension and thus are front runners of good clinical practice in hypertension management in their countries. An important task of the Excellence Centres is also to be active in research, particularly in projects conducted by the European Society of Hypertension. The ongoing BP-CON-ESH project on the rate of blood pressure control in hypertensive patients addresses the most elementary,but at the same timethe most important aspect in hypertension management, because the observed low rates of blood pressure control is the reason why hypertension is still today the leading cause of death worldwide.
In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres.
The primary goals will be to determine the global, regional and country rates of hypertension control in Europe. Other goals will be to identify global and regional factors associated with blood pressure control in different European regions. It is well known that the overall control of hypertension in Europe is still insufficient. However, the problem is not the same across Europe. Differences in healthcare systems exist among European countries, and in some countries government healthcare system only partially reimburse costs of antihypertensive therapy. There are also differences in gross national product, educational levels, salt consumption, prevalence of obesity and other aspects. These could cause dissimilarities in hypertension prevalence, achieved blood pressure control and cardiovascular mortality among European regions.
The results obtained in the BP-CON-ESH project will be used to refine treatment strategies for improvement of blood pressure control and will serve as a basis for assessing future changes and trends in Europe.
- Keywords
- Blood pressure, Hypertension, Control, European, Excellence centres
- Medical subject headings
- Risk Reduction Behavior, White Coat Hypertension, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Difference in blood pressure values between ESH Excellence Centres
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Oct 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Hypertension
- Responsible party
- Principal investigator, Prof. Bojan Jelaković, Clinical Hospital Centre Zagreb
- Investigators
- Bojan Jelaković, MD, PhD, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295434
- Sponsor's protocol ID
- BP-CON-ESH
- Acronym
- BP-CON
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the European Society of Hypertension on Blood Pressure Control in ESH Excellence Centres
- ClinicalTrials.gov ID
- NCT04295434
- Acronym / sponsor ID
- BP-CON / BP-CON-ESH
- Keywords
- Blood pressure, Hypertension, Control, European, Excellence centres
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Collaborators
- European Society of Hypertension
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 4 Mar 2020 (actual)
- 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.
In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres. The primary goals will be to determine the global, regional and country rates of hypertension control in Europe. Other goals will be to identify global and regional factors associated with blood pressure control in different European regions. The results obtained in the BP-CON-ESH project will be used to refine treatment strategies for improvement of blood pressure control and will serve as a basis for assessing future changes and trends in Europe.
Detailed description
The most important task of the European Society of Hypertension is to improve blood pressure treatment and increase blood pressure control, thus decreasing cardiovascular risk, premature cardiovascular and renal morbidity and mortality, with in addition a reduction of health-care costs. More than a decade ago, the European Society of Hypertension established a network of Excellence Centres. Those centres are leading institutions for the diagnosis and treatment of hypertension and thus are front runners of good clinical practice in hypertension management in their countries. An important task of the Excellence Centres is also to be active in research, particularly in projects conducted by the European Society of Hypertension. The ongoing BP-CON-ESH project on the rate of blood pressure control in hypertensive patients addresses the most elementary,but at the same timethe most important aspect in hypertension management, because the observed low rates of blood pressure control is the reason why hypertension is still today the leading cause of death worldwide.
In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres.
The primary goals will be to determine the global, regional and country rates of hypertension control in Europe. Other goals will be to identify global and regional factors associated with blood pressure control in different European regions. It is well known that the overall control of hypertension in Europe is still insufficient. However, the problem is not the same across Europe. Differences in healthcare systems exist among European countries, and in some countries government healthcare system only partially reimburse costs of antihypertensive therapy. There are also differences in gross national product, educational levels, salt consumption, prevalence of obesity and other aspects. These could cause dissimilarities in hypertension prevalence, achieved blood pressure control and cardiovascular mortality among European regions.
The results obtained in the BP-CON-ESH project will be used to refine treatment strategies for improvement of blood pressure control and will serve as a basis for assessing future changes and trends in Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension that are under supervision of excellence centres participating in the study.
Key inclusion criteria (1 listed)
- Signed informed consent
Key exclusion criteria (6 listed)
- Pregnancy and breastfeeding
- Terminal malignancy, reduced life expectancy (<6 months)
- Amputated limb
- Dementia
- Patients living in a nursing home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure control
Time frame: Through study completion, an average of 1 year
Difference in blood pressure values between ESH Excellence Centres
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- ESH website with relevant informations on BP CON studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bojan Jelaković, MD, PhD principal investigator
Clinical Hospital Centre Zagreb
46 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Lifestyle Risk Reduction, run by Clinical Hospital Centre Zagreb at 46 sites in 22 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Greece, Germany, Italy, Belgium, Czechia and 17 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojan Jelaković, MD, PhD (00385959030751, jelakovicbojan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2020.