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

September 25, 2023 updated by: Sandosh Padmanabhan, University of Glasgow

Longer-term Effects of COVID-19 on Blood Vessels and Blood Pressure (LOCHINVAR) Phenotyping Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Coronavirus Disease-19 (COVID-19) pandemic is one of the biggest medical challenges in recent years. Whilst COVID-19 primarily affects the lungs, causing interstitial pneumonitis and severe acute respiratory distress syndrome, it also affects multiple organ systems, including the cardiovascular system(1-3). There are documented associations between severity of disease/mortality risk and advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer).(4,5) The most common complications include cardiac dysrhythmia(6,7), cardiac injury(8,9), myocarditis, heart failure, pulmonary embolism10 and disseminated intravascular coagulation(11).

The SARS-CoV-2 virus uses the ACE2 receptor (ACE2) to enter type 2 pneumocytes, macrophages, perivascular pericytes, and cardiomyocytes.(12) This may lead to myocardial dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque instability, and myocardial infarction.(12) In addition, ACE2 is expressed in several other organs including cells lining the blood vessels (endothelial cells), ACE2 is a key player in the renin-angiotensin system (RAS) which is important in blood pressure regulation and is a target for some of the commonly used drugs used in the treatment of blood pressure. 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 in those with COVID-19 infection.(12) Furthermore, there is evidence that the normally occurring bacteria in the gut (gut microbiome) directly influences the makeup of the human immune system and has been implicated in severity of COVID-19 as well as in the magnitude of the immune system response to SARS-CoV-2 infection(13).

This study (LOCHINVAR) is based on the pilot study "COVID-19 blood pressure endothelium interaction study" (OBELIX), funded by the Chief Scientific Office. Preliminary results showed that participants who had COVID-19 infection had an 8.6mmHg increase in their average 24hr systolic blood pressure, compared to those that did not have COVID-19 infection. The investigators will increase our recruitment of potential participants to meet our sample size of 150 participants (75 SARS-CoV-2 +ve cases and 75 SARS-CoV-2 -ve cases) built on OBELIX. This study will allow us to have a better understanding of the risks of developing high blood pressure or uncontrolled blood pressure following COVID-19 infection. This will allow doctors to be able to make a recommendation on the current/long term management of people with high blood pressure beyond the pandemic.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 8QQ
        • Professor Sandosh Padmanabhan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients admitted through Queen Elizabeth University Hospital (QEUH) receiving units with suspected/confirmed COVID-19 during 01/09/2020-31/12/2021 and who are alive at discharge. Clinically suspected COVID-19 should have either fever, new onset cough and/or anosmia/dysgeusia and/or ≥2 of the following presenting features (fatigue/generalised weakness, headache, myalgia, sore throat/coryzal symptoms, breathlessness, anorexia/nausea/vomiting, diarrhoea, contact with known COVID-19 positive case). OBELIX participants who have given consent previously will be re-contacted.

Description

Inclusion Criteria:

  • Age 30-60 years
  • Admission between 01/09/2020 - 31/12/2021
  • Clinically suspected or Confirmed COVID-19 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test confirmed COVID-19 on admission
  • No history of hypertension or current drug treatment for hypertension

Controls

  1. Age 30-60
  2. No history of hypertension
  3. No antihypertensive drugs
  4. Confirmed RT-PCR test negative and admission through Queen Elizabeth University Hospital immediate assessment unit and acute receiving units 01/09/2020 to 31/12/2021 or no history of SARS-CoV-2 infection or COVID-19

Exclusion Criteria:

Inability to give informed consent/lack of capacity 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
  • Oral Corticosteroid (chronic use)
  • Immunosuppressive agents
  • Oral NSAIDs (chronic use)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
SARS-CoV-2 +ve cases
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
Control
SARS-CoV-2 -ve cases
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour ABPM Systolic Blood Pressure
Time Frame: 12 months
Average 24 hour Ambulatory Blood Pressure Monitoring - Systolic Blood Pressure , (all day and night) at 12 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour ABPM Diastolic Blood Pressure
Time Frame: 12 months and 18 months
Average 24 hour Ambulatory Blood Pressure Monitoring - Diastolic Blood Pressure, 24hr (all day and night) at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Day ABPM Systolic Blood Pressure
Time Frame: 12 months and 18 months
Day Ambulatory Blood Pressure Monitoring (Average Systolic Blood Pressure) 8 am to 8 pm at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Day ABPM Diastolic Blood Pressure
Time Frame: 12 months and 18 months
Day Ambulatory Blood Pressure Monitoring (Average Diastolic Blood Pressure), 8 am to 8 pm at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Night ABPM Systolic Blood Pressure
Time Frame: 12 months and 18 months
Night Ambulatory Blood Pressure Monitoring (Average Systolic Blood Pressure) 8pm to 8 am at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Night ABPM Diastolic Blood Pressure
Time Frame: 12 months and 18 months
Night Ambulatory Blood Pressure Monitoring (Average Diastolic Blood Pressure) 8pm to 8 am at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
24-hour ABPM Heart Rate
Time Frame: 12 months and 18 months
24 hour Ambulatory Blood Pressure Monitoring - Heart Rate, 24hr (all day and night) at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
24-hour Urine Sodium
Time Frame: 12 months and 18 months
24-hour Urine Sodium at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Flow Mediated Dilatation
Time Frame: 12 months and 18 months
% Brachial Flow Mediated Dilatation at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Exercise tolerance - distance walked in 6 minutes
Time Frame: 12 months and 18 months
Exercise tolerance distance walked in 6 minutes at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Quality of life and mood - difference in longitudinal changes in QoL and mood between groups
Time Frame: 12 months and 18 months
Patient Health Questionaire-9 (Minimal Depression 0-4, Mild Depression 5 - 9, Moderate Depression 10-14, Moderately Severe Depression 15 - 19, Severe Depression 20-27) and Euroqol (EQ5D-3L) Questionnaire (Mean EQ-5D and Standard Deviation) at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Mean Home Systolic Blood Pressure
Time Frame: 12 months and 18 months
Mean Home Blood Pressure Measurements - Systolic Blood Pressure at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Mean Home Diastolic Blood Pressure
Time Frame: 12 months and 18 months
Mean Home Blood Pressure Measurements - Diastolic Blood Pressure at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Day Home Systolic Blood Pressure
Time Frame: 12 months and 18 months
Average Day Home Blood Pressure Measurements - Systolic Blood Pressure at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Evening Home Systolic Blood Pressure
Time Frame: 12 months and 18 months
Average Evening Home Blood Pressure Measurements - Systolic Blood Pressure at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Day Home Diastolic Blood Pressure
Time Frame: 12 months and 18 months
Average Day Home Blood Pressure Measurements - Diastolic Blood Pressure at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months
Evening Home Diastolic Blood Pressure
Time Frame: 12 months and 18 months
Average Evening Home Blood Pressure Measurements - Diastolic Blood Pressure at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
12 months and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

September 21, 2023

Study Completion (Actual)

September 21, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN20CA501
  • 21/WS/0075 (Other Identifier: NHS Greater Glasgow and Clyde)
  • 299056 (Other Identifier: IRAS)
  • RG2690/21/24 (Other Grant/Funding Number: HEART Research UK)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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