- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798208
Effect of Covid-19 on Hypertension
The Long-term Impact of COVID-19 on Blood Pressure: A Retrospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fars
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Shiraz, Fars, Iran, Islamic Republic of, 55318
- Education Developmen Center
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Shiraz, Fars, Iran, Islamic Republic of, 51318
- Cardiology Ward Shiraz University of Medical Sciences
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Outside Of The US
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Shiraz, Outside Of The US, Iran, Islamic Republic of, 55318
- Professor kojuri cardiology clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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hypertensive
Covid patients with exacerbated hypertension or new hypertension post covid
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Taking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal
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non hypertensive
Covid patients with no change in blood pressure pre and post covid
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Taking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of blood pressure
Time Frame: 2 years
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any change in blood pressure level before and after covid infection
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2 years
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Secondary Outcome Measures
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,
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2 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.SUMS.MED.REC.1401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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