Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409847
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
COVID Hypertension Diagnostic Test: ABPM Diagnostic Test: ECG 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Blood Pressure Endothelium Interaction Study
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: ABPM
24 hour ambulatory blood pressure monitoring

Diagnostic Test: ECG
Electrocardiogram

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: ABPM
24 hour ambulatory blood pressure monitoring

Diagnostic Test: ECG
Electrocardiogram

Diagnostic Test: FMD
Flow mediated dilatation

Diagnostic Test: PWV
Pulse wave velocity

Diagnostic Test: Rarefaction
nailbed capillaroscopy


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ABPM systolic blood pressure [ Time Frame: 24 hours (all day and night) ]
    Ambulatory Blood Pressure Monitoring systolic blood pressure


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
blood and urine samples for vascular phenotpying marker, immuno phenotyping markers and future biomarker studies

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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).
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409847


Contacts
Layout table for location contacts
Contact: Katriona Brooksbank 01413302418 katriona.brooksbank@glasgow.ac.uk
Contact: Rhian M Touyz 01413307775 rhian.touyz@glasgow.ac.uk

Locations
Layout table for location information
United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04409847    
Other Study ID Numbers: GN20CA245
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases