Clinical trial NCT04409847: COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)
Official title: COVID-19 Blood Pressure Endothelium Interaction Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Hypertension
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2020-06-01
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: ABPM systolic blood pressure
timeFrame: 24 hours (all day and night)
Secondary outcomes:
measure: 24-hr ABPM DBP
timeFrame: 24 hours (all day and night)
measure: day ABPM SBP
timeFrame: 8am to 8pm
measure: day ABPM DBP
timeFrame: 8am to 8pm
measure: night ABPM SBP
timeFrame: 8pm to 8am
measure: night ABPM DBP
timeFrame: 8pm to 8am
measure: dipping status
timeFrame: 24 hours (all day and night)
measure: morning surge
timeFrame: 24 hours (all day and night)
measure: 24 hour ABPM HR
timeFrame: 24hr (all day and night)
measure: day ABPM HR
timeFrame: 8 am to 8 pm
measure: night ABPM HR
timeFrame: 8pm to 8 am
measure: Immune phenotyping
timeFrame: at baseline
measure: Microparticle assessments
timeFrame: at baseline
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
References: