COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)

يمكن للمستخدمين المسجلين فقط ترجمة المقالات

الدخول التسجيل فى الموقع

يتم حفظ الارتباط في الحافظة

الحالةلم يتم التجنيد بعد

الرعاة

NHS Greater Glasgow and Clyde

المتعاونون

University of Glasgow

تجربة سريرية: NCT04409847

BioSeek: nct04409847

الكلمات الدالة

نبذة مختصرة

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.

وصف

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.

تواريخ

آخر التحقق:	04/30/2020
تم الإرسال لأول مرة:	05/21/2020
تم إرسال التسجيل المقدر:	05/27/2020
أول نشر:	05/31/2020
تم إرسال آخر تحديث:	05/27/2020
آخر تحديث تم نشره:	05/31/2020
تاريخ بدء الدراسة الفعلي:	05/31/2020
تاريخ الإنجاز الأساسي المقدر:	12/30/2020
التاريخ المتوقع لانتهاء الدراسة:	05/30/2021

حالة أو مرض

COVID

Hypertension

التدخل / العلاج

Diagnostic Test: ABPM

Diagnostic Test: ECG

Diagnostic Test: FMD

Diagnostic Test: PWV

Diagnostic Test: Rarefaction

مرحلة

مجموعات الذراع

ذراع	التدخل / العلاج
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

معايير الأهلية

الأعمار المؤهلة للدراسة	30 Years إلى 30 Years
الأجناس المؤهلة للدراسة	All
طريقة أخذ العينات	Non-Probability Sample
يقبل المتطوعين الأصحاء	نعم
المعايير	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)

النتيجة

مقاييس النتائج الأولية

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

Ambulatory Blood Pressure Monitoring systolic blood pressure

مقاييس النتائج الثانوية

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)

الكلمات الدالة

كوفيد 19

protease

سرطان

مرض فيروس كورونا

احتشاء

انصمام رئوي

انسداد وعائي

سمنة

التهاب العضلة القلبية

قصور القلب

نوبة قلبية

تخثر منتشر داخل الأوعية

angiotensin