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NCT Number: NCT04409847

COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)

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.

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Key information

Conditions

COVID Cardiovascular Diseases Hypertension Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ABPM

Diagnostic Test

24 hour ambulatory blood pressure monitoring

ECG

Diagnostic Test

Electrocardiogram

FMD

Diagnostic Test

Flow mediated dilatation

PWV

Diagnostic Test

Pulse wave velocity

Rarefaction

Diagnostic Test

nailbed capillaroscopy

Primary outcomes

  1. ABPM systolic blood pressure

    Time frame: 24 hours (all day and night)

    Ambulatory Blood Pressure Monitoring systolic blood pressure

Secondary outcomes

  1. 24-hr ABPM DBP

    Time frame: 24 hours (all day and night)

    Ambulatory Blood Pressure Monitoring diastolic blood pressure

  2. day ABPM SBP

    Time frame: 8am to 8pm

    Day Ambulatory Blood Pressure Monitoring systolic blood pressure

  3. day ABPM DBP

    Time frame: 8am to 8pm

    Day Ambulatory Blood Pressure Monitoring diastolic blood pressure

  4. night ABPM SBP

    Time frame: 8pm to 8am

    Night Ambulatory Blood Pressure Monitoring systolic blood pressure

  5. night ABPM DBP

    Time frame: 8pm to 8am

    Night Ambulatory Blood Pressure Monitoring diastolic blood pressure

  6. dipping status

    Time frame: 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

  7. morning surge

    Time frame: 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.

  8. 24 hour ABPM HR

    Time frame: 24hr (all day and night)

    24 hour Ambulatory Blood Pressure Monitoring heart rate

  9. day ABPM HR

    Time frame: 8 am to 8 pm

    Day Ambulatory Blood Pressure Monitoring heart rate

  10. night ABPM HR

    Time frame: 8pm to 8 am

    Night Ambulatory Blood Pressure Monitoring heart rate

  11. Immune phenotyping

    Time frame: 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

  12. Microparticle assessments

    Time frame: at baseline

    microparticles are being assessed as biomarkers and biovectors of vascular damage and endothelial dysfunction

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

COVID-19 Blood Pressure Endothelium Interaction Study

Acronym: OBELIX

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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