COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX) (OBELIX)

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; COVID
• Intervention / Treatment: Diagnostic test: ECG; Diagnostic test: ABPM; Diagnostic test: FMD; Diagnostic test: PWV; Diagnostic test: Rarefaction

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

• Study Contact: Name: Katriona Brooksbank; Phone Number: 01413302418; Email: katriona.brooksbank@glasgow.ac.uk
• Study Contact Backup: Name: Rhian M Touyz; Phone Number: 01413307775; Email: rhian.touyz@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID+ PCR; Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19	Diagnostic test: ECG; Electrocardiogram; Diagnostic test: ABPM; 24 hour ambulatory blood pressure monitoring; Diagnostic test: FMD; Flow mediated dilatation; Diagnostic test: PWV; Pulse wave velocity; Diagnostic test: Rarefaction; nailbed capillaroscopy
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	Diagnostic test: ECG; Electrocardiogram; Diagnostic test: ABPM; 24 hour ambulatory blood pressure monitoring; Diagnostic test: FMD; Flow mediated dilatation; Diagnostic test: PWV; Pulse wave velocity; Diagnostic test: Rarefaction; nailbed capillaroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABPM systolic blood pressure	Ambulatory Blood Pressure Monitoring systolic blood pressure	24 hours (all day and night)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hr ABPM DBP	Ambulatory Blood Pressure Monitoring diastolic blood pressure	24 hours (all day and night)
day ABPM SBP	Day Ambulatory Blood Pressure Monitoring systolic blood pressure	8am to 8pm
day ABPM DBP	Day Ambulatory Blood Pressure Monitoring diastolic blood pressure	8am to 8pm
night ABPM SBP	Night Ambulatory Blood Pressure Monitoring systolic blood pressure	8pm to 8am
night ABPM DBP	Night Ambulatory Blood Pressure Monitoring diastolic blood pressure	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	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.	24 hours (all day and night)
24 hour ABPM HR	24 hour Ambulatory Blood Pressure Monitoring heart rate	24hr (all day and night)
day ABPM HR	Day Ambulatory Blood Pressure Monitoring heart rate	8 am to 8 pm
night ABPM HR	Night Ambulatory Blood Pressure Monitoring heart rate	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	at baseline
Microparticle assessments	microparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction	at baseline

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: GN20CA245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No