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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04295434
Other study ID # BP-CON-ESH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date March 1, 2021

Study information

Verified date March 2020
Source Clinical Hospital Centre Zagreb
Contact Bojan Jelakovic, MD, PhD
Phone 00385959030751
Email jelakovicbojan@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date March 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Signed informed consent

Exclusion Criteria:

- Pregnancy and breastfeeding

- Terminal malignancy, reduced life expectancy (<6 months)

- Amputated limb

- Dementia

- Patients living in a nursing home

- Unsigned informed consent

Study Design


Locations

Country Name City State
Armenia Center of Preventive Cardiology, Yerevan Yerevan
Austria Klinikum Wels-Grieskirchen Wels
Belgium Erasmus Hospital Brussels
Belgium CHU de Liège Liège
Belgium Ambroise Paré University Hospital Mons
Bulgaria University Hospital "St. Anna" Sofia
Croatia University hospital centre Zagreb Zagreb Grad Zagreb
Czechia Charles University Medical School and University Hospital Plzen
Czechia Center for Hypertension, Charles University, Prague Praha
Czechia Institute for Clinical and Experimental Medicine (IKEM) and Thomayer Hospital, Prague Praha
Estonia Tallinn Hypertension Excellence Centre Tallinn
Germany Hypertension Center Berlin Charité Berlin
Germany Hypertoniezentrum Bonn Bonn
Germany Medizinische Hochschule Hannover Hanover
Germany Universitätskliniken des Saarlandes Homburg
Germany Hypertension Center Munich Munich
Greece Hypertension and Cardiovascular Prevention Clinic, 3rd Department of Medicine, Evangelismos Hospital Athens
Greece Hypertension Clinic, Cardiology Department, Asklepeion Hospital Athens
Greece Hypertension Clinic, Department of Cardiology, KAT General Hospital Athens
Greece Hypertension Clinic, University Hospital Laiko Athens
Greece University of Athens, Hippokration Hospital Athens
Greece University Hospital of Heraklion Heraklion
Greece Hypertension Center, Department of Nephrology, University Hospital of Ioannina Ioánnina
Greece Aristotle University of Thessaloniki, Papageorgiou General Hospital Thessaloníki
Greece Hypertension Center, Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki Thessaloníki
Greece Hypertension Outpatient Clinic, 1st Propedeutic Dept. of Internal Medicine, AHEPA Hospital Thessaloníki
Israel Assuta Ashdod University Hospital Ashdod
Italy Centre of Prevention and Treatment of Arterial Hypertension and Cardiovascular Risk Factors Brescia
Italy Ospedale Niguarda, Dip. De Gasperis e Università di Milano Bicocca Milan
Italy S. Luca Hospital, Istituto Auxologico Italiano Milan
Italy Napoli Hypertension Excellence Centre, Federico II Clinic Research Center for Hypertension and Related Conditions Napoli
Italy Excellence Centre of Hypertension, Department of Medical Sciences, University of Torino Torino
Lebanon American University Center, Hypertension/Vascular Medicine Division (Associated Centre) Beirut
Lithuania Kaunas Hypertension Excellence Centre Kaunas
Netherlands University Hospital Maastricht Maastricht
Netherlands Radboud University of Nijmegen Medical Center Nijmegen
Poland Department of Internal Medicine, Hypertension and Vascular Diseases, Warsaw Medical University Warsaw
Portugal Centro Hospitalar do Alto Ave, Minho University Guimarães
Romania Department of Cardiology and Internal Medicine, Emergency Clinical Hospital of Bucharest Bucharest
Serbia Centre for Hypertension of the Clinical Centre of Serbia Belgrad
Spain Hipertensión Clinic, Internal Medicine, Hospital Clinico, University of Barcelona Barcelona
Spain Hypertension Clinic, Nephrology Department, Reina Sofia University Hospital Córdoba
Sweden Danderyd University Hospital Stockholm
Ukraine National Scientific Center "The M.D. Strazhesko Institute of Cardiology" Kyiv
United Kingdom St. Bartholomew's Royal London School of Medicine & Dentistry London
United Kingdom The Pearl-Rose Clinic (Hypertension & Cardiovascular Risk), Hammersmith Hospital, London

Sponsors (2)

Lead Sponsor Collaborator
Clinical Hospital Centre Zagreb European Society of Hypertension

Countries where clinical trial is conducted

Armenia,  Austria,  Belgium,  Bulgaria,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Israel,  Italy,  Lebanon,  Lithuania,  Netherlands,  Poland,  Portugal,  Romania,  Serbia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure control Difference in blood pressure values between ESH Excellence Centres Through study completion, an average of 1 year
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