COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)

Hypertension Clinical Trial

— OBELIX  

Official title:

COVID-19 Blood Pressure Endothelium Interaction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409847
• Other study ID #: GN20CA245
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID
• Hypertension

Intervention

Diagnostic Test:
• ABPM
24 hour ambulatory blood pressure monitoring
• ECG
Electrocardiogram
• FMD
Flow mediated dilatation
• PWV
Pulse wave velocity
• Rarefaction
nailbed capillaroscopy

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

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