Condition category
Infections and Infestations
Date applied
03/08/2020
Date assigned
04/08/2020
Last edited
06/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Up to 1 in 5 patients hospitalised by COVID-19 have evidence of heart muscle injury as measured from a blood test. This is associated with a high death rate. Using an MRI scan of the heart we aim to investigate how often, and in what way, the heart becomes damaged, and how the heart recovers 6 months later.

Who can participate?
Adults over 18 years, diagnosed with SARS-CoV-2 infection (COVID-19) with indication of heart damage (raised cardiac biomarker [Troponin]).

What does the study involve?
Patients will be required to have a cardiac MRI, an electrocardiogram (ECG) and to complete a 6 minute walk test and questionnaire at baseline and 6 months later. An optional blood test will also be taken for genetic and immunological testing.

What are the possible benefits and risks of participating?
MRI: A small proportion of patients do not tolerate MRI scanning due to claustrophobia, and patients who are known to be claustrophobic will therefore not be recruited. Some patients may experience claustrophobia once in the MRI scanner. Every effort will be made to reduce this sensation, as per normal clinical routine MRI scanning, but if a participant cannot tolerate the procedure the scan will be stopped immediately. Very rarely allergic reactions can occur (less than 1 in 3,000) but the department is equipped to manage allergic reactions if they happen.
6 minute walk test: Chairs will be placed at intervals to ensure the patient can stop and rest if required and the test will be performed with a Registered Nurse.
ECG: This is a non-invasive record of a heart tracing, patients are positioned on a bed and the test can take up to 15 minutes. Slight discomfort may be experienced when removing the sticker placed on the patient’s chest or limbs.
Blood sample: A single blood sample will be drawn if the patient consents, patient can experience some discomfort during the procedure.
Confidentiality: The Sponsor will take reasonable steps to protect the confidentiality of information. Patients will be assigned a unique identifier number. Any participant records/images that are transferred to the University of Glasgow Clinical Trials Unit for analysis will contain the unique identifier only; participant names or any information which would make the participant identifiable will not be transferred.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
April 2020 to August 2021.

Who is funding the study?
1. UK Research and Innovation
2. National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. John Greenwood (scientific), j.greenwood@leeds.ac.uk
Kathryn Somers (public), kathryn.somers@nhs.net
Dr Laura Jones (public), l.m.jones@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Greenwood

ORCID ID

http://orcid.org/0000-0002-2861-0914

Contact details

University of Leeds and Leeds Teaching Hospitals NHS Trust
Dept. of Cardiology
X39
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)1133925481
j.greenwood@leeds.ac.uk

Type

Public

Additional contact

Ms Kathryn Somers

ORCID ID

Contact details

Department of Cardiology
Former Ward 39
Gilbert Scott Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 3922358
kathryn.somers@nhs.net

Type

Public

Additional contact

Dr Laura Jones

ORCID ID

Contact details

Leeds Institute of Cardiovascular and Metabolic Medicine
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)7921121815
l.m.jones@leeds.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil Known

Protocol/serial number

CD20/133244, IRAS 285147

Study information

Scientific title

Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: the COVID-HEART study

Acronym

COVID-HEART study

Study hypothesis

To describe the prevalence and extent of heart muscle injury in patients with COVID-19 and determinants (blood biomarkers, severity of acute infection, genetics, and comorbidities) of adverse clinical outcome in this population.

Ethics approval

Approved 30/06/2020, North West - Greater Manchester South Research Ethics Committee, (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8063; gmsouth.rec@hra.nhs.uk), ref: 20/NW/0292

Study design

Multi-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Assessment of heart muscle damage secondary to coronavirus disease (COVID-19)

Intervention

Firstly, we will establish a de-identified national image repository for all heart MRI scans already performed clinically in patients with COVID-19 infection (work package 1, WP1). We will seek consent from patients in multiple NHS hospitals with moderate to severe laboratory-confirmed COVID-19 infection (defined as those requiring hospital admission for >2 days or needing ventilatory assistance) to use their images in the repository. Patients will also be invited to participate in the rest of the study (WP2).

For WP2 we will enrol patients with COVID-19 infection who have had a blood test that has indicated heart muscle injury (and any participants from WP1 that choose to participate in the rest of the study). Participants will have an MRI scan (if they haven't already), complete a quality of life questionnaire and have a six-minute walk test. Patients will be required to give written consent for their original data to be used for the study and to participate in this work package. This will enable us to investigate how often, and in what way, the heart becomes damaged. Patients will also be asked to provide (with additional consent) an optional blood sample for genetic and immunological testing. Assuming the mean prevalence of heart muscle injury is 12 % (from previous studies) with a precision of 3.5%, 95% confidence level and a 10% drop out rate, 370 patients would be required for this work package.

All participants for WP2 will be invited for a follow up visit 6 months later and will undergo a repeat ECG, heart MRI scan, an assessment of validated quality of life questionnaire and six-minute walk test. This will allow us to assess how heart muscle damage and recovery is affected by age, sex, ethnicity and other medical conditions (such as diabetes, high blood pressure, heart disease and narrowing of blood vessels), as these are also known to be associated with high death rates. From the baseline heart MRI scans we will also seek to improve the bedside diagnosis of heart muscle injury from a standard 12 lead ECG (which can have marked similarities to heart attack), by comparing these to a contemporary, UK, clinical trial ECG following heart attack dataset as the reference standard (data already acquired and available).

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Effect of COVID-19 on the heart at baseline and 6 months:
1. Heart abnormalities assessed using MRI
2. Heart rhythm and electrical activity assessed using ECG
3. Walking ability assessed using 6-min walking test
4. Patient-reported health status assessed using SF-36
5. Health-related quality of life assessed using EQ-5D

Secondary outcome measures

The influence of comorbidities, age, and genetics measured using medical records monitored from baseline up to 1 year (an optional blood test will be performed at baseline for genetic and immunological testing)

Overall trial start date

16/04/2020

Overall trial end date

31/07/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥ 18 years
2. Diagnosed with SARS-CoV-2 infection with a raised cardiac biomarker (Troponin)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

370

Participant exclusion criteria

1. Unable/unwilling to consent
2. Significant renal impairment (eGFR<30ml/min/m²)
3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
4. Contraindications to MRI (pacemaker, intra-orbital debris, intra-orbital debris, intra-auricular implants, intracranial clips, severe claustrophobia
5. Known hypersensitivity to gadolinium-based contrast agents

Recruitment start date

01/08/2020

Recruitment end date

31/07/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds Teaching Hospital Trust Great George Street
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Gartnavel Royal Hospital
NHS Greater Glasgow and Clyde 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Trial participating centre

Leicester Royal Infirmary
University Hospital of Leicester NHS Trust Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford University Hospital NHS Foundation Trust Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Trust Headquarters Marlborough Street
Bristol
BS1 3NU
United Kingdom

Trial participating centre

Royal Free Hospital
Royal Free London NHS Foundation Trust Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Edinburgh Royal Infirmary
NHS Lothian 51 Little France Cres
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

The Royal London Hospital
Barts Health NHS Trust 80 Newark Street
London
E1 2ES
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

St. Thomas Hospital
Guy's and St. Thomas' NHS Foundation Trust Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Royal Brompton Hospital
Royal Brompton & Harefield NHS Foundation Trust Sydney Street
London
SW3 6NP
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
NHS Grampian Polwarth Building Health Sciences Building Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Trial participating centre

Southampton General Hospital
University Hospital Southampton NHS Foundation Trust Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Liverpool Heart and Chest Hospital NHS Foundation Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
University Hospital Birmingham NHS Foundation Trust Mindelsohn Way Edgbaston
Birmingham
B15 2GW
United Kingdom

Trial participating centre

Pindersfields Hospital
Mid Yorkshire Hospitals NHS Trust Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Royal Devon and Exeter Hospital NHS Foundation Trust Barrack Rd
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Faculty Research Office
Room 9.29
Level 9
Worsley Building
Leeds
LS2 9NL
United Kingdom
+44 (0)1133437587
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/07/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/08/2020: Internal review. 04/08/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).