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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05013931

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Blood Pressure

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Outcome Measures

Primary Outcome Measures

To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kelvin KF Tsoi, Associate Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05013931

Other Study ID Numbers:

2021.449

First Posted:

Aug 19, 2021

Last Update Posted:

Aug 19, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 19, 2021