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Clinical Trials/NCT04409847
NCT04409847
Completed
N/A

COVID-19 Blood Pressure Endothelium Interaction Study

NHS Greater Glasgow and Clyde1 site in 1 country52 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
52
Locations
1
Primary Endpoint
ABPM systolic blood pressure
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
July 1, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

ABPM systolic blood pressure

Time Frame: 24 hours (all day and night)

Ambulatory Blood Pressure Monitoring systolic blood pressure

Secondary Outcomes

  • Immune phenotyping(at baseline)
  • 24-hr ABPM DBP(24 hours (all day and night))
  • day ABPM SBP(8am to 8pm)
  • day ABPM DBP(8am to 8pm)
  • 24 hour ABPM HR(24hr (all day and night))
  • night ABPM HR(8pm to 8 am)
  • night ABPM SBP(8pm to 8am)
  • night ABPM DBP(8pm to 8am)
  • dipping status(24 hours (all day and night))
  • morning surge(24 hours (all day and night))
  • day ABPM HR(8 am to 8 pm)
  • Microparticle assessments(at baseline)

Study Sites (1)

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