COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)
- Conditions
- COVIDHypertension
- Interventions
- Diagnostic Test: ABPMDiagnostic Test: ECGDiagnostic Test: FMDDiagnostic Test: PWVDiagnostic Test: Rarefaction
- Registration Number
- NCT04409847
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID+ PCR PWV Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 COVID+ PCR Rarefaction Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 COVID- PCR ABPM 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 COVID+ PCR FMD Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 COVID+ PCR ECG Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 COVID+ PCR ABPM Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 COVID- PCR ECG 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 COVID- PCR FMD 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 COVID- PCR PWV 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 COVID- PCR Rarefaction 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
- Primary Outcome Measures
Name Time Method ABPM systolic blood pressure 24 hours (all day and night) Ambulatory Blood Pressure Monitoring systolic blood pressure
- Secondary Outcome Measures
Name Time Method Immune phenotyping at baseline Immune phenotyping includes cellular and humoral markers of immune cell activation and senescence within populations of key leukocyte subsets e.g. lymphocytes and monocytes
24-hr ABPM DBP 24 hours (all day and night) Ambulatory Blood Pressure Monitoring diastolic blood pressure
day ABPM SBP 8am to 8pm Day Ambulatory Blood Pressure Monitoring systolic blood pressure
day ABPM DBP 8am to 8pm Day Ambulatory Blood Pressure Monitoring diastolic blood pressure
24 hour ABPM HR 24hr (all day and night) 24 hour Ambulatory Blood Pressure Monitoring heart rate
night ABPM HR 8pm to 8 am Night Ambulatory Blood Pressure Monitoring heart rate
night ABPM SBP 8pm to 8am Night Ambulatory Blood Pressure Monitoring systolic blood pressure
night ABPM DBP 8pm to 8am Night Ambulatory Blood Pressure Monitoring diastolic blood pressure
dipping status 24 hours (all day and night) 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
morning surge 24 hours (all day and night) 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.
day ABPM HR 8 am to 8 pm Day Ambulatory Blood Pressure Monitoring heart rate
Microparticle assessments at baseline microparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction
Trial Locations
- Locations (1)
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom