Covid19NCT05013931
Short-term Effect of COVID-19 Vaccine on Blood Pressure
An observational study of Covid19 and Blood Pressure, run by Chinese University of Hong Kong.
Trial summary
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Blood Pressure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who will be receiving COVID-19 vaccination will be invited to the study.
Who may be able to join
- Subjects who will be receiving COVID-19 vaccination
- Subjects who understand Chinese to make an informed consent
Who cannot join
- Skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)
About this study
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM
Read the detailed description
Safety of coronavirus disease 19 (COVID-19) vaccines has been a concern. Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines. One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT). Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure.
A case series report was published on Hypertension in June 2021 on documented stage III hypertension within minutes of vaccination (mRNA vaccines) in a vaccination centre located in Switzerland. The study reported 9 subjects experienced a surge in blood pressure to stage III hypertension after vaccination. Yet the study had a few shortcomings. There was not baseline measurement of blood pressure. Surge of blood pressure shortly after vaccination could be due to nervousness or white coat effect. Thus surge of blood pressure within minutes of vaccination could be not due to vaccination. There was not long-term follow-up on blood pressure measurement after vaccination.
Further to the case series report, another prospective study in Italy investigated effect of mRNA vaccine on blood pressure and heart rate. The study was conducted as a survey. There was 5.3% of respondents (6/113) reported rise of home blood pressure of at least 10mmHg after 1st dose vaccination, compared with home blood pressure prior to vaccination. Among these subjects, 4 of them required anti-hypertensive medication intensification.
Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure before and after vaccination. Use of ambulatory blood pressure monitoring (ABPM) before and after vaccination helps to understand the details on short-term blood pressure changes.
- Conditions
- Covid19, Blood Pressure
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin KF Tsoi, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013931
- Sponsor's protocol ID
- 2021.449
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of COVID-19 Vaccine on Blood Pressure
- ClinicalTrials.gov ID
- NCT05013931
- Acronym / sponsor ID
- 2021.449
- Conditions
- Covid19, Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 19 Aug 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.
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM
Detailed description
Safety of coronavirus disease 19 (COVID-19) vaccines has been a concern. Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines. One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT). Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure.
A case series report was published on Hypertension in June 2021 on documented stage III hypertension within minutes of vaccination (mRNA vaccines) in a vaccination centre located in Switzerland. The study reported 9 subjects experienced a surge in blood pressure to stage III hypertension after vaccination. Yet the study had a few shortcomings. There was not baseline measurement of blood pressure. Surge of blood pressure shortly after vaccination could be due to nervousness or white coat effect. Thus surge of blood pressure within minutes of vaccination could be not due to vaccination. There was not long-term follow-up on blood pressure measurement after vaccination.
Further to the case series report, another prospective study in Italy investigated effect of mRNA vaccine on blood pressure and heart rate. The study was conducted as a survey. There was 5.3% of respondents (6/113) reported rise of home blood pressure of at least 10mmHg after 1st dose vaccination, compared with home blood pressure prior to vaccination. Among these subjects, 4 of them required anti-hypertensive medication intensification.
Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure before and after vaccination. Use of ambulatory blood pressure monitoring (ABPM) before and after vaccination helps to understand the details on short-term blood pressure changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who will be receiving COVID-19 vaccination will be invited to the study.
Key inclusion criteria (2 listed)
- Subjects who will be receiving COVID-19 vaccination
- Subjects who understand Chinese to make an informed consent
Key exclusion criteria (1 listed)
- Skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)
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
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Blood Pressure, run by Chinese University of Hong Kong.
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 2 inclusion and 1 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 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2021.