COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliBado kuajiri

Wadhamini

NHS Greater Glasgow and Clyde

Washirika

University of Glasgow

JARIBIO LA KLINIKI: NCT04409847

BioSeek: nct04409847

Maneno muhimu

disseminated intravascular coagulation

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	04/30/2020
Iliyowasilishwa Kwanza:	05/21/2020
Uandikishaji uliokadiriwa Uliwasilishwa:	05/27/2020
Iliyotumwa Kwanza:	05/31/2020
Sasisho la Mwisho Liliwasilishwa:	05/27/2020
Sasisho la Mwisho Lilichapishwa:	05/31/2020
Tarehe halisi ya kuanza kwa masomo:	05/31/2020
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	12/30/2020
Tarehe ya Kukamilisha Utafiti:	05/30/2021

Hali au ugonjwa

COVID

Hypertension

Uingiliaji / matibabu

Diagnostic Test: ABPM

Diagnostic Test: ECG

Diagnostic Test: FMD

Diagnostic Test: PWV

Diagnostic Test: Rarefaction

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
COVID+ PCR Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19
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

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	30 Years Kwa 30 Years
Jinsia Inastahiki Kujifunza	All
Njia ya sampuli	Non-Probability Sample
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - Admission between 01/04/2020 and 31/05/2020 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)

Matokeo

Hatua za Matokeo ya Msingi

1. ABPM systolic blood pressure [24 hours (all day and night)]

Ambulatory Blood Pressure Monitoring systolic blood pressure

Hatua za Matokeo ya Sekondari

1. 24-hr ABPM DBP [24 hours (all day and night)]

Ambulatory Blood Pressure Monitoring diastolic blood pressure

2. day ABPM SBP [8am to 8pm]

Day Ambulatory Blood Pressure Monitoring systolic blood pressure

3. day ABPM DBP [8am to 8pm]

Day Ambulatory Blood Pressure Monitoring diastolic blood pressure

4. night ABPM SBP [8pm to 8am]

Night Ambulatory Blood Pressure Monitoring systolic blood pressure

5. night ABPM DBP [8pm to 8am]

Night Ambulatory Blood Pressure Monitoring diastolic blood pressure

6. dipping status [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 [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 [24hr (all day and night)]

24 hour Ambulatory Blood Pressure Monitoring heart rate

9. day ABPM HR [8 am to 8 pm]

Day Ambulatory Blood Pressure Monitoring heart rate

10. night ABPM HR [8pm to 8 am]

Night Ambulatory Blood Pressure Monitoring heart rate

COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)

Maneno muhimu

covid-19

protease

saratani

coronavirus infections

infarction

pulmonary embolism

embolism

kunona

myocarditis

heart failure

shtuko la moyo