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COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)

COVID-19 Blood Pressure Endothelium Interaction Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04409847
Acronym
OBELIX
Enrollment
52
Registered
2020-06-01
Start date
2020-06-01
Completion date
2021-07-01
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, Hypertension

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.

Interventions

DIAGNOSTIC_TESTABPM

24 hour ambulatory blood pressure monitoring

DIAGNOSTIC_TESTECG

Electrocardiogram

DIAGNOSTIC_TESTFMD

Flow mediated dilatation

DIAGNOSTIC_TESTPWV

Pulse wave velocity

DIAGNOSTIC_TESTRarefaction

nailbed capillaroscopy

Sponsors

University of Glasgow
CollaboratorOTHER
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
ABPM systolic blood pressure24 hours (all day and night)Ambulatory Blood Pressure Monitoring systolic blood pressure

Secondary

MeasureTime frameDescription
day ABPM SBP8am to 8pmDay Ambulatory Blood Pressure Monitoring systolic blood pressure
day ABPM DBP8am to 8pmDay Ambulatory Blood Pressure Monitoring diastolic blood pressure
night ABPM SBP8pm to 8amNight Ambulatory Blood Pressure Monitoring systolic blood pressure
night ABPM DBP8pm to 8amNight Ambulatory Blood Pressure Monitoring diastolic blood pressure
dipping status24 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
24-hr ABPM DBP24 hours (all day and night)Ambulatory Blood Pressure Monitoring diastolic blood pressure
24 hour ABPM HR24hr (all day and night)24 hour Ambulatory Blood Pressure Monitoring heart rate
day ABPM HR8 am to 8 pmDay Ambulatory Blood Pressure Monitoring heart rate
night ABPM HR8pm to 8 amNight Ambulatory Blood Pressure Monitoring heart rate
Immune phenotypingat baselineImmune phenotyping includes cellular and humoral markers of immune cell activation and senescence within populations of key leukocyte subsets e.g. lymphocytes and monocytes
Microparticle assessmentsat baselinemicroparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction
morning surge24 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026