Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-12-03
2022-12-30
Brief Summary
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Detailed Description
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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:
1. Assessment of BP (i.e., average 24hSBP, average 24hDBP) changes (deltas) from values recorded in the year preceding the COVID-19 pandemic to BP (i.e., average 24hSBP, average 24hDBP) values measured during the lockdown (Group 1).
2. Assessment of BP (i.e., average 24hSBP, average 24hDBP) changes (deltas) from values recorded in the pre-pandemic period with 9-15 months' time interval (Group 2).
3. Differences in BP (i.e., average 24hSBP, average 24hDBP) changes (deltas) assessed by ABPM from Visit 1 to Visit 2 between Group 1 and Group 2.
Secondary outcomes:
1. Assessment of BP (i.e., average 24hSBP, average 24hDBP) changes predictors in Group 1 and Group 2.
2. Assessment of differences in averaged Daytime (awake) BP changes assessed by ABPM from Visit 1 to Visit 2 between Group 1 and Group 2.
3. Assessment of differences in averaged Night-time (asleep) BP changes assessed by ABPM from Visit 1 to Visit 2 between Group 1 and Group 2.
4. Assessment of white - coat, masked, and resistant hypertension prevalence in Group 1 and Group 2.
5. Assessment of the extent of asleep BP fall, and dipper/non-dipper phenotypes prevalence in Group 1 and Group 2.
6. Analyses of BP short-term (24hABPM) variability
Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Office systolic, diastolic blood pressure and heart rate available from the day (+/- 1 month) of ABPM recording. If office BP are not available, please provide first BP measurement from ABPM recording.
3. Availability of at least two valid ABPM recordings in 9-15 months interval. a. Group 1 with the second ABPM during the pandemic period: i. First ABPM (visit 1) obtained 9-15 months before the second ABPM recording, but not later than 31.12.2019 ii. Second ABPM (visit 2) obtained during the pandemic period 01.04.2020 - 31.03.2021 b. Group 2 with both ABPM recordings before the pandemic period: i. First ABPM (visit 1) obtained 9-15 months before the Second ABPM ii. Second ABPM (visit 2) obtained between 01.01.2019 - 31.12.2019
Exclusion Criteria
2. Hypertension in pregnancy.
3. Device based treatment of hypertension.
4. Development of heart failure, cardiac surgery, myocardial infarction, or cancer between ABPM measurements.
5. Parkinson disease.
6. Alcohol or drug abuse.
18 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
National Institute of Cardiology, Warsaw, Poland
OTHER
Responsible Party
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Principal Investigators
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Andrzej Januszewicz, Prof
Role: STUDY_CHAIR
National Institute of Cardiology, Warszawa, Poland
Locations
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I Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, UJ CM
Krakow, , Poland
Countries
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Central Contacts
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Facility Contacts
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Wiktoria Wojciechowska, MD, PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ESHABPMCOVID-19_01
Identifier Type: -
Identifier Source: org_study_id