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LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)

NCT05087290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-09-26

No results posted yet for this study

Summary

The COVID-19 pandemic is the biggest medical challenge in decades. Individuals with pre-existing cardiovascular diseases have a higher risk of severe disease and death from COVID-19. The SARS-CoV-2 virus causes infection by targeting a molecule on the walls of the cells lining the lungs and the blood vessels leading to injury. There are concerns that after recovery from COVID-19, the damage sustained by these cells may have long-term consequences including high blood pressure, stroke and heart attacks. The burden of high blood pressure as a result of the pandemic is unknown and a greater understanding of COVID-19 impact on blood pressure and its underlying mechanisms is urgently needed.

LOCHINVAR is based on our pilot study "COVID-19 blood pressure endothelium interaction study" (OBELIX,NCT04409847, IRAS 284453), which found that patients with normal blood pressure at the time of hospital admission with COVID-19 showed a nine-point higher blood pressure ≥12 weeks after recovery, compared to a group without COVID-19. LOCHINVAR will extend the OBELIX study aiming to establish if COVID-19 increases the risk of developing high blood pressure and investigating underlying mechanisms through detailed measurements of blood pressure, blood vessel function, hormones and chemicals in the blood, urine and stool.

The investigators will invite 150 adults without pre-existing high blood pressure who were discharged from hospital after an admission: half with COVID-19 and half without. Baseline visit will be ≥12 weeks after discharge for measurements of blood pressure, tests of heart and blood vessel health, blood, urine and stool samples along with questionnaires on mood and quality of life. Two further study visits follow, at 12 and 18 months.

This study will generate crucial evidence on the long-term impact of COVID-19 on blood pressure along with information on potential mechanisms of this effect with immediate, transferable impact on clinical practice and inform risk mitigation measures.

Conditions

Interventions

OTHER

Cases

All performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires Optional: Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor

OTHER

Controls

All performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires Optional: Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor

Sponsors & Collaborators

  • University of Glasgow

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-09-21
Completion
2023-09-21

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087290 on ClinicalTrials.gov