COVID-19NCT05798208
Effect of Covid-19 on Hypertension
An observational study of COVID-19 and Hypertension, run by Shiraz University of Medical Sciences at 3 sites in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 39 to 71 years
- Conditions the study is for
- COVID-19, Hypertension
- What is being tested?
- blood pressure measurement
- How many people
- 5,355 participants
- Where
- 3 sitesIran
- Study dates
- 15 Feb 2020to 20 Feb 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 39 to 71 years
- All sexes
- Adult, Older adult
Study population: Covid patients with recorded blood pressure before and after covid infection
Who may be able to join
- 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
Who cannot join
- Age under 18
- Hospital admission due to COVID-19
- Corticosteroid therapy,
- History of systemic inflammatory disease
- kidney disease
- liver disease
- Immunocompromised patients
Trial locations and contacts
3 sites in 1 country.
Iran3 sites
Cardiology Ward Shiraz University of Medical Sciences
Shiraz, Fars, 51318
Education Developmen Center
Shiraz, Fars, 55318
Professor kojuri cardiology clinic
Shiraz, Outside of the US, 55318
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Hypertension
- Being tested
- blood pressure measurement
- Keywords
- covid-19, hypertension, blood pressure
- Medical subject headings
- COVID-19, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurementDiagnostic test
Taking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal
| Study group | Role | What they receive |
|---|---|---|
| hypertensive | Covid patients with exacerbated hypertension or new hypertension post covid Receives: Diagnostic Test: blood pressure measurement | |
| non hypertensive | Covid patients with no change in blood pressure pre and post covid Receives: Diagnostic Test: blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of blood pressure
any change in blood pressure level before and after covid infection
Measured: 2 years
Secondary outcomes (1)
predictors of changes in blood pressure
history of any risk factor for cardiac disease, age, sex,
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Feb 2020
- Primary completion28 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 5,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798208
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1401
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available based on rational request
Publications
Azami P, Vafa RG, Heydarzadeh R, Sadeghi M, Amiri F, Azadian A, Khademolhosseini A, Yousefi M, Montaseri M, Hosseini N, Hosseini SA, Kojuri J. Evaluation of blood pressure variation in recovered COVID-19 patients at one-year follow-up: a retrospective cohort study. BMC Cardiovasc Disord. 2024 May 7;24(1):240. doi: 10.1186/s12872-024-03916-w.
PubMed 38714940
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Impact of COVID-19 on Blood Pressure: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05798208
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1401
- Conditions
- COVID-19, Hypertension
- Keywords
- covid-19, hypertension, blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,355 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 4 Apr 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive | – | Diagnostic Test: blood pressure measurementCovid patients with exacerbated hypertension or new hypertension post covid |
| non hypertensive | – | Diagnostic Test: blood pressure measurementCovid patients with no change in blood pressure pre and post covid |
Who may qualify
- Ages
- 39 to 71 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Covid patients with recorded blood pressure before and after covid infection
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Age under 18
- Hospital admission due to COVID-19
- Corticosteroid therapy,
- History of systemic inflammatory disease
- kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure measurementTaking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal | Diagnostic test | hypertensive, non hypertensive |
Primary outcome
change of blood pressure
Time frame: 2 years
any change in blood pressure level before and after covid infection
1 secondary outcome
predictors of changes in blood pressure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 38714940Azami P, Vafa RG, Heydarzadeh R, Sadeghi M, Amiri F, Azadian A, Khademolhosseini A, Yousefi M, Montaseri M, Hosseini N, Hosseini SA, Kojuri J. Evaluation of blood pressure variation in recovered COVID-19 patients at one-year follow-up: a retrospective cohort study. BMC Cardiovasc Disord. 2024 May 7;24(1):240. doi: 10.1186/s12872-024-03916-w.
- Individual participant dataSharing planned: No. Data are available based on rational request
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Hypertension, run by Shiraz University of Medical Sciences at 3 sites in Iran.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of blood pressure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798208, which also lists 1 linked publication.
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 4 Apr 2023.