ESH ABPM COVID-19 STUDY

Ambulatory Blood Pressure Clinical Trial

— ABMP COVID-19  

Official title:

European Society of Hypertension Ambulatory Blood Pressure Monitoring COVID-19 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167240
• Other study ID #: ESHABPMCOVID-19_01
• Status: Recruiting
• Start date: December 3, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Wiktoria Wojciechowska, MD PhD
• Phone: +4812 4002150
• Email: esh.abpm.covid19[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2022
• Est. primary completion date: June 3, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pharmacologically treated hypertensive patients.

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:

1. Confirmed secondary hypertension.

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.

Related Conditions & MeSH terms

• Ambulatory Blood Pressure
• COVID-19

Locations

Country	Name	City	State
Poland	I Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, UJ CM	Kraków

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland	Jagiellonian University Collegium Medicum, Krakow, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. Erratum in: Cardiovasc Res. 2021 Sep 28;117(11):2394. — View Citation

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. Review. — View Citation

Mena L, Pintos S, Queipo NV, Aizpúrua JA, Maestre G, Sulbarán T. A reliable index for the prognostic significance of blood pressure variability. J Hypertens. 2005 Mar;23(3):505-11. — View Citation

Peçanha 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. — View Citation

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. 2021 Feb 5. pii: zwab010. doi: 10.1093/eurjpc/zwab010. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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