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| Name | Class |
|---|---|
| Jagiellonian University | OTHER |
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Aim of the study is to determine the impact of the COVID-19 pandemic on blood pressure profiles and variability as assessed by ambulatory blood pressure monitoring (ABPM) through the comparison of ABPM data obtained before and during the COVID-19 lockdown in already treated hypertensive patients
Recruitment for the study will be conducted according to the principles outlined in the Helsinki declaration for investigations in human subjects. The Ethics Committee of each Center must approve the protocol. We will collect clinical data, including office and ambulatory blood pressure of patients with treated arterial hypertension at least 18 years of age.
The study will include two different groups . Group 1 - will constitute of participants with two repeated ABPM recordings (visits): the second visit performed between 01.04.2020 - 31.03.2021 (i.e., during the COVID-19 pandemic announced by the WHO in 11.03.2020) and the first visit 9-15 months before the second ABPM recording, but not later than 31.12.2019.
Group 2 - will constitute of participants with two repeated ABPM recordings (visits) - both visits performed before the pandemic: the second visit in 01.01.2019 - 31.12.2019 and the first visit 9-15 months before the second.
Primary outcome. Difference of changes (deltas) in averaged 24-hour systolic and diastolic BP assessed by ABPM from Visit 1 to Visit 2 between Group 1 and Group 2.
Primary outcome evaluation:
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Group 1 - will constitute of participants with two repeated ABPM recordings (visits): the second visit performed between 01.04.2020 - 31.03.2021 (i.e., during the COVID-19 pandemic announced by the WHO in 11.03.2020) and the first visit 9-15 months before the second ABPM recording, but not later than 31.12.2019. | ||
| Group 2 | Group 2 - will constitute of participants with two repeated ABPM recordings (visits) - both visits performed before the pandemic: the second visit in 01.01.2019 - 31.12.2019 and the first visit 9-15 months before the second. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference of changes in averaged 24-hour systolic and diastolic BP | Difference of changes (deltas) in averaged 24-hour systolic and diastolic BP assessed by ABPM from Visit 1 to Visit 2 between Group 1 and Group 2. | Visit 2 01.04.2020 - 31.03.2021 and Visit 1 and the first visit 9-15 months before the second ABPM recording, but not later than 31.12.2019 |
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Inclusion Criteria:
Exclusion Criteria:
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We will collect clinical data, including office and ambulatory blood pressure of patients with treated arterial hypertension at least 18 years of age
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiktoria Wojciechowska, MD PhD | Contact | +4812 4002150 | esh.abpm.covid19@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrzej Januszewicz, Prof | National Institute of Cardiology, Warszawa, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, UJ CM | Recruiting | Krakow | 3-688 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33395152 | Background | Kreutz R, Dobrowolski P, Prejbisz A, Algharably EAE, Bilo G, Creutzig F, Grassi G, Kotsis V, Lovic D, Lurbe E, Modesti PA, Pappaccogli M, Parati G, Persu A, Polonia J, Rajzer M, de Timary P, Weber T, Weisser B, Tsioufis K, Mancia G, Januszewicz A; European Society of Hypertension COVID-19 Task Force Review. Lifestyle, psychological, socioeconomic and environmental factors and their impact on hypertension during the coronavirus disease 2019 pandemic. J Hypertens. 2021 Jun 1;39(6):1077-1089. doi: 10.1097/HJH.0000000000002770. | |
| 32412779 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Background |
| Pecanha T, Goessler KF, Roschel H, Gualano B. Social isolation during the COVID-19 pandemic can increase physical inactivity and the global burden of cardiovascular disease. Am J Physiol Heart Circ Physiol. 2020 Jun 1;318(6):H1441-H1446. doi: 10.1152/ajpheart.00268.2020. Epub 2020 May 15. |
| 33273364 | Background | The corona-virus disease 2019 pandemic compromised routine care for hypertension: a survey conducted among excellence centers of the European Society of Hypertension. J Hypertens. 2021 Jan;39(1):190-195. doi: 10.1097/HJH.0000000000002703. |
| 32293003 | Background | Kreutz R, Algharably EAE, Azizi M, Dobrowolski P, Guzik T, Januszewicz A, Persu A, Prejbisz A, Riemer TG, Wang JG, Burnier M. Hypertension, the renin-angiotensin system, and the risk of lower respiratory tract infections and lung injury: implications for COVID-19. Cardiovasc Res. 2020 Aug 1;116(10):1688-1699. doi: 10.1093/cvr/cvaa097. |
| 33899916 | Background | Pengo MF, Albini F, Guglielmi G, Mollica C, Soranna D, Zambra G, Zambon A, Bilo G, Parati G. Home blood pressure during COVID-19-related lockdown in patients with hypertension. Eur J Prev Cardiol. 2022 Mar 25;29(3):e94-e96. doi: 10.1093/eurjpc/zwab010. No abstract available. |
| 33710173 | Background | Stergiou GS, Palatini P, Parati G, O'Brien E, Januszewicz A, Lurbe E, Persu A, Mancia G, Kreutz R; European Society of Hypertension Council and the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens. 2021 Jul 1;39(7):1293-1302. doi: 10.1097/HJH.0000000000002843. No abstract available. |
| 34304583 | Background | Hoshide S, Kario K. Morning Surge in Blood Pressure and Stroke Events in a Large Modern Ambulatory Blood Pressure Monitoring Cohort: Results of the JAMP Study. Hypertension. 2021 Sep;78(3):894-896. doi: 10.1161/HYPERTENSIONAHA.121.17547. Epub 2021 Jul 26. No abstract available. |
| 15716690 | Background | Mena L, Pintos S, Queipo NV, Aizpurua JA, Maestre G, Sulbaran T. A reliable index for the prognostic significance of blood pressure variability. J Hypertens. 2005 Mar;23(3):505-11. doi: 10.1097/01.hjh.0000160205.81652.5a. |
| 17885548 | Background | Bilo G, Giglio A, Styczkiewicz K, Caldara G, Maronati A, Kawecka-Jaszcz K, Mancia G, Parati G. A new method for assessing 24-h blood pressure variability after excluding the contribution of nocturnal blood pressure fall. J Hypertens. 2007 Oct;25(10):2058-66. doi: 10.1097/HJH.0b013e32829c6a60. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |