ESH ABPM COVID-19 STUDY

NCT05167240 | Unknown DMC

• 1 other identifier: ESHABPMCOVID-19_01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ambulatory Blood Pressure

Keywords

ABPM, COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will collect clinical data, including office and ambulatory blood pressure of patients with treated arterial hypertension at least 18 years of age

You may qualify if:

• Pharmacologically treated hypertensive patients.
• 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.
• 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

You may not qualify if:

• Confirmed secondary hypertension.
• Hypertension in pregnancy.
• Device based treatment of hypertension.
• Development of heart failure, cardiac surgery, myocardial infarction, or cancer between ABPM measurements.
• Parkinson disease.
• Alcohol or drug abuse.

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• Jagiellonian University: collaborator

Study Sites (1)

I Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, UJ CM

Krakow, 3-688, Poland

RECRUITING

Related Publications (9)

• 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.

  PMID: 33395152 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.

  PMID: 32412779 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.

  PMID: 33273364 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.

  PMID: 32293003 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.

  PMID: 33899916 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.

  PMID: 33710173 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.

  PMID: 34304583 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.

  PMID: 15716690 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.

  PMID: 17885548 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrzej Januszewicz, Prof

  National Institute of Cardiology, Warszawa, Poland

  STUDY CHAIR

Central Study Contacts

Wiktoria Wojciechowska, MD PhD

CONTACT

+4812 4002150; esh.abpm.covid19@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: December 22, 2021
• Study Start: December 3, 2021
• Primary Completion: June 3, 2022
• Study Completion: December 30, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)