Effect of Covid-19 on Hypertension

April 2, 2023 updated by: Javad Kojuri, Shiraz University of Medical Sciences

The Long-term Impact of COVID-19 on Blood Pressure: A Retrospective Cohort Study

In this single center , retrospective study, 5355 covid patient were selected from 2020 to 2022, with recorded blood pressure before covid and recording after covid. Blood pressure before and after covid were compared, by pair T test.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

design and participants This single-center retrospective cohort study was conducted at an outpatient cardiology clinic in Shiraz, Iran, between February 15, 2020, and December 28, 2022. We evaluated patients with a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by RNA reverse-transcriptase polymerase-chain-reaction assays from nasopharyngeal or oropharyngeal swab specimens according to World Health Organization guidelines (12). Two physicians (PA, MY) reviewed the patients' electronic medical records, including demographics, comorbidities, vital signs, treatments, and outcomes. Ambiguities were resolved by a third author (MM).

The current study included all COVID-19 patients who had at least one documented blood pressure measurement in the three months preceding infection and one documented measurement one to three months following recovery. The following patients were excluded: those under 18, with hospital admission due to COVID-19, who received corticosteroid therapy, those with a history of systemic inflammatory disease, kidney or liver, immunocompromised patients, and those who switched their antihypertensive regimen during the study. Finally, 5,355 eligible patients were investigated . The primary outcome was to assess BP variation following infection (particularly a prolonged rise in BP) among non-hospitalized COVID-19 patients. The secondary outcome was to identify the predictor factors of BP variation.

The present study was approved by the Ethics Committee of Shiraz University of Medical Sciences under code IR.SUMS.MED.REC.1401.465 , and the need for informed consent was waived due to the study's retrospective nature and the absence of patient identifiers in the presented data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of, 55318
        • Education Developmen Center
      • Shiraz, Fars, Iran, Islamic Republic of, 51318
        • Cardiology Ward Shiraz University of Medical Sciences
    • Outside Of The US
      • Shiraz, Outside Of The US, Iran, Islamic Republic of, 55318
        • professor Kojuri cardiology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

39 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Covid patients with recorded blood pressure before and after covid infection

Description

Inclusion Criteria:

  • All COVID-19 patients who had at least one documented blood pressure measurement in the three months preceding infection and one documented measurement one to three months following recovery

Exclusion Criteria:

  • Age under 18
  • Hospital admission due to COVID-19
  • Corticosteroid therapy,
  • History of systemic inflammatory disease
  • kidney disease
  • liver disease
  • Immunocompromised patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
hypertensive
Covid patients with exacerbated hypertension or new hypertension post covid
Diagnostic test: blood pressure measurement
Taking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal
non hypertensive
Covid patients with no change in blood pressure pre and post covid
Diagnostic test: blood pressure measurement
Taking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of blood pressure
Time Frame: 2 years
any change in blood pressure level before and after covid infection
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
predictors of changes in blood pressure
Time Frame: 2 years
history of any risk factor for cardiac disease, age, sex,
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IR.SUMS.MED.REC.1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available based on rational request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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