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NCT05013931 Clinical Trial

Short-term Effect of COVID-19 Vaccine on Blood Pressure

Covid19 Clinical Trial

Official title:
Short-term Effect of COVID-19 Vaccine on Blood Pressure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05013931
Other study ID # 2021.449
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2021
Est. completion date January 2023

Study information
Verified date August 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date January 2023
Est. primary completion date July 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects who will be receiving COVID-19 vaccination - Subjects who understand Chinese to make an informed consent Exclusion Criteria: - Skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM 1 day
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