Ambulatory Blood PressureABMP COVID-19NCT05167240
ESH ABPM COVID-19 STUDY
An observational study of Ambulatory Blood Pressure, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Blood Pressure
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 3 Dec 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
I Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, UJ CM
Krakow, 3-688
Wiktoria Wojciechowska, MD, PhD, +4812 400 2150, esh.abpm.covid19@gmail.com
About this study
Official title: European Society of Hypertension Ambulatory Blood Pressure Monitoring COVID-19 Study
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
Read the detailed 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:
- 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).
- 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).
- 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:
- Assessment of BP (i.e., average 24hSBP, average 24hDBP) changes predictors in Group 1 and Group 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.
- 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.
- Assessment of white - coat, masked, and resistant hypertension prevalence in Group 1 and Group 2.
- Assessment of the extent of asleep BP fall, and dipper/non-dipper phenotypes prevalence in Group 1 and Group 2.
- Analyses of BP short-term (24hABPM) variability
- Conditions
- Ambulatory Blood Pressure
- Keywords
- ABPM, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start3 Dec 2021
- Primary completion3 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ambulatory Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University
- Responsible party
- Sponsor
- Investigators
- Andrzej Januszewicz, Prof, Study chair, National Institute of Cardiology, Warszawa, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167240
- Sponsor's protocol ID
- ESHABPMCOVID-19_01
- Acronym
- ABMP COVID-19
- Status last verified
- Nov 2021
- First submitted
- 21 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33395152Pecanha 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.
PubMed 32412779The 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.
PubMed 33273364Kreutz 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.
PubMed 32293003Pengo 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.
PubMed 33899916Stergiou 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.
PubMed 33710173Hoshide 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.
PubMed 34304583Mena 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.
PubMed 15716690Bilo 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.
PubMed 17885548
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Society of Hypertension Ambulatory Blood Pressure Monitoring COVID-19 Study
- ClinicalTrials.gov ID
- NCT05167240
- Acronym / sponsor ID
- ABMP COVID-19 / ESHABPMCOVID-19_01
- Conditions
- Ambulatory Blood Pressure
- Keywords
- ABPM, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Jagiellonian University
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 3 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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:
- 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).
- 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).
- 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:
- Assessment of BP (i.e., average 24hSBP, average 24hDBP) changes predictors in Group 1 and Group 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.
- 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.
- Assessment of white - coat, masked, and resistant hypertension prevalence in Group 1 and Group 2.
- Assessment of the extent of asleep BP fall, and dipper/non-dipper phenotypes prevalence in Group 1 and Group 2.
- Analyses of BP short-term (24hABPM) variability
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of changes in averaged 24-hour systolic and diastolic BP
Time frame: 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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Background: PubMed 33395152Kreutz 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.
- Background: PubMed 32412779Pecanha 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.
- Background: PubMed 33273364The 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.
- Background: PubMed 32293003Kreutz 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.
- Background: PubMed 33899916Pengo 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.
- Background: PubMed 33710173Stergiou 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.
- Background: PubMed 34304583Hoshide 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.
- Background: PubMed 15716690Mena 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.
- Background: PubMed 17885548Bilo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Januszewicz, Prof study chair
National Institute of Cardiology, Warszawa, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Blood Pressure, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wiktoria Wojciechowska, MD PhD (+4812 4002150, esh.abpm.covid19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of changes in averaged 24-hour systolic and diastolic BP (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167240, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.