COVIDOBELIXNCT04409847
COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)
An observational study of COVID and Hypertension, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- COVID, Hypertension
- What is being tested?
- ABPM, ECG and FMD
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 1 Jul 2021
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients admitted through QEUH immediate assessment unit and acute receiving units with suspected or confirmed COVID-19 during 01/04/20 - 31/12/20 and who are alive at discharge. Clinically suspected COVID-19 should have at least two of the following presenting features (fever, new onset cough, fatigue, myalgia, breathlessness, GI symptoms, anosmia/dysgeusia, contact with known COVID-19 positive patient).
Who may be able to join
- Admission between 01/04/2020 and 31/12/2020 Clinically suspected or PCR confirmed COVID-19 Age 30-60 years No history of hypertension or current drug treatment for hypertension
Who cannot join
- Inability to give informed consent/lack of capacity Non-English speakers BMI >40 eGFR <60 ml/min Pregnancy History of Cancer within 5 years Persistent atrial fibrillation Severe illness, at investigator discretion Prescription of BP lowering drugs Corticosteroid (chronic use) Immunosupressive agents NSAIDs (chronic use)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Blood Pressure Endothelium Interaction Study
The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. There are documented associations between severity of disease and risk of death and To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section.
5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer). The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart failure, pulmonary embolism and disseminated intravascular coagulation.
Read more
It is thought that the mechanism of action of the virus involves binding to a host transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and immune cells and cause further damage. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis.
This study aims to look closely at the health of the vascular system of patients after being treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study is essential so that clinicians treating patients with high blood pressure understand the impact of the condition and these hypertension medicines in the context of the current COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients currently prescribed these medications or who are newly diagnosed with hypertension.
Read the detailed description
COVID-19 is pandemic and, though it primarily affects the lungs, there is evidence of cardiovascular system involvement. Mechanistically, SARS-CoV-2, following proteolytic cleavage of its S protein by a serine protease, binds to the transmembrane angiotensin-converting enzyme 2 (ACE2) -a homologue of ACE-to enter type 2 pneumocytes, macrophages, perivascular pericytes, and cardiomyocytes. This may lead to myocardial dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque instability, and myocardial infarction. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers alter prognosis.
- Conditions
- COVID, Hypertension
- Being tested
- ABPM, ECG, FMD, PWV, Rarefaction
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABPMDiagnostic test
24 hour ambulatory blood pressure monitoring
ECGDiagnostic test
Electrocardiogram
FMDDiagnostic test
Flow mediated dilatation
PWVDiagnostic test
Pulse wave velocity
RarefactionDiagnostic test
nailbed capillaroscopy
| Study group | Role | What they receive |
|---|---|---|
| COVID+ PCR | Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 Receives: Diagnostic Test: ABPM; Diagnostic Test: ECG; Diagnostic Test: FMD; Diagnostic Test: PWV; Diagnostic Test: Rarefaction | |
| COVID- PCR | subjects admitted with COVID-19 like symptoms but are SARS-CoV-2 PCR-ve and have CXR or CT chest that show low probability of COVID-19 will form the control group Receives: Diagnostic Test: ABPM; Diagnostic Test: ECG; Diagnostic Test: FMD; Diagnostic Test: PWV; Diagnostic Test: Rarefaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABPM systolic blood pressure
Ambulatory Blood Pressure Monitoring systolic blood pressure
Measured: 24 hours (all day and night)
Secondary outcomes (12)
24-hr ABPM DBP
Ambulatory Blood Pressure Monitoring diastolic blood pressure
Measured: 24 hours (all day and night)
day ABPM SBP
Day Ambulatory Blood Pressure Monitoring systolic blood pressure
Measured: 8am to 8pm
day ABPM DBP
Day Ambulatory Blood Pressure Monitoring diastolic blood pressure
Measured: 8am to 8pm
night ABPM SBP
Night Ambulatory Blood Pressure Monitoring systolic blood pressure
Measured: 8pm to 8am
night ABPM DBP
Night Ambulatory Blood Pressure Monitoring diastolic blood pressure
Measured: 8pm to 8am
dipping status
The fall in pressure, called the "dip", is defined as the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value
Measured: 24 hours (all day and night)
morning surge
he morning surge was defined as the difference between the mean systolic blood pressure during the 2 hours after waking and arising minus the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep.
Measured: 24 hours (all day and night)
24 hour ABPM HR
24 hour Ambulatory Blood Pressure Monitoring heart rate
Measured: 24hr (all day and night)
day ABPM HR
Day Ambulatory Blood Pressure Monitoring heart rate
Measured: 8 am to 8 pm
night ABPM HR
Night Ambulatory Blood Pressure Monitoring heart rate
Measured: 8pm to 8 am
Immune phenotyping
Immune phenotyping includes cellular and humoral markers of immune cell activation and senescence within populations of key leukocyte subsets e.g. lymphocytes and monocytes
Measured: at baseline
Microparticle assessments
microparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409847
- Sponsor's protocol ID
- GN20CA245
- Acronym
- OBELIX
- Status last verified
- Feb 2021
- First submitted
- 22 May 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Blood Pressure Endothelium Interaction Study
- ClinicalTrials.gov ID
- NCT04409847
- Acronym / sponsor ID
- OBELIX / GN20CA245
- Conditions
- COVID, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 1 Jun 2020 (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.
The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. There are documented associations between severity of disease and risk of death and To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section.
5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer). The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart failure, pulmonary embolism and disseminated intravascular coagulation.
It is thought that the mechanism of action of the virus involves binding to a host transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and immune cells and cause further damage. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis.
This study aims to look closely at the health of the vascular system of patients after being treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study is essential so that clinicians treating patients with high blood pressure understand the impact of the condition and these hypertension medicines in the context of the current COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients currently prescribed these medications or who are newly diagnosed with hypertension.
Detailed description
COVID-19 is pandemic and, though it primarily affects the lungs, there is evidence of cardiovascular system involvement. Mechanistically, SARS-CoV-2, following proteolytic cleavage of its S protein by a serine protease, binds to the transmembrane angiotensin-converting enzyme 2 (ACE2) -a homologue of ACE-to enter type 2 pneumocytes, macrophages, perivascular pericytes, and cardiomyocytes. This may lead to myocardial dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque instability, and myocardial infarction. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers alter prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID+ PCR | – | Diagnostic Test: ABPM, Diagnostic Test: ECG, Diagnostic Test: FMD, Diagnostic Test: PWV, Diagnostic Test: RarefactionSubjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 |
| COVID- PCR | – | Diagnostic Test: ABPM, Diagnostic Test: ECG, Diagnostic Test: FMD, Diagnostic Test: PWV, Diagnostic Test: Rarefactionsubjects admitted with COVID-19 like symptoms but are SARS-CoV-2 PCR-ve and have CXR or CT chest that show low probability of COVID-19 will form the control group |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients admitted through QEUH immediate assessment unit and acute receiving units with suspected or confirmed COVID-19 during 01/04/20 - 31/12/20 and who are alive at discharge. Clinically suspected COVID-19 should have at least two of the following presenting features (fever, new onset cough, fatigue, myalgia, breathlessness, GI symptoms, anosmia/dysgeusia, contact with known COVID-19 positive patient).
Key inclusion criteria (1 listed)
- Admission between 01/04/2020 and 31/12/2020 Clinically suspected or PCR confirmed COVID-19 Age 30-60 years No history of hypertension or current drug treatment for hypertension
Key exclusion criteria (1 listed)
- Inability to give informed consent/lack of capacity Non-English speakers BMI >40 eGFR <60 ml/min Pregnancy History of Cancer within 5 years Persistent atrial fibrillation Severe illness, at investigator discretion Prescription of BP lowering drugs Corticosteroid (chronic use) Immunosupressive agents NSAIDs (chronic use)
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 |
|---|---|---|
| ABPM24 hour ambulatory blood pressure monitoring | Diagnostic test | COVID+ PCR, COVID- PCR |
| ECGElectrocardiogram | Diagnostic test | COVID+ PCR, COVID- PCR |
| FMDFlow mediated dilatation | Diagnostic test | COVID+ PCR, COVID- PCR |
| PWVPulse wave velocity | Diagnostic test | COVID+ PCR, COVID- PCR |
| Rarefactionnailbed capillaroscopy | Diagnostic test | COVID+ PCR, COVID- PCR |
Primary outcome
ABPM systolic blood pressure
Time frame: 24 hours (all day and night)
Ambulatory Blood Pressure Monitoring systolic blood pressure
12 secondary outcomes
24-hr ABPM DBP
Time frame: 24 hours (all day and night)
day ABPM SBP
Time frame: 8am to 8pm
day ABPM DBP
Time frame: 8am to 8pm
night ABPM SBP
Time frame: 8pm to 8am
night ABPM DBP
Time frame: 8pm to 8am
dipping status
Time frame: 24 hours (all day and night)
morning surge
Time frame: 24 hours (all day and night)
24 hour ABPM HR
Time frame: 24hr (all day and night)
day ABPM HR
Time frame: 8 am to 8 pm
night ABPM HR
Time frame: 8pm to 8 am
Immune phenotyping
Time frame: at baseline
Microparticle assessments
Time frame: at baseline
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 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Hypertension, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 1 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
ABPM systolic blood pressure (time frame: 24 hours (all day and night)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.