COVID-19 effects on the heart
| ISRCTN | ISRCTN58667920 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58667920 |
| IRAS number | 285147 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | CD20/133244, IRAS 285147 |
- Submission date
- 03/08/2020
- Registration date
- 04/08/2020
- Last edited
- 02/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
(added 10/05/2021)
Study duration and funding
The study is sponsored by the University of Leeds and is expected to run from 01/08/2020-31/07/ 2021. The NIHR-BHF Cardiovascular Partnership have designated this project as a “COVID19 Cardiovascular Disease UK Flagship Project”. The trial has been badged as an Urgent Public Health study by the NIHR and funding has been confirmed for NIHR CRN support approved by the UKRI-DHSC COVID-19 Rapid Response Rolling Call.
Contact information
Scientific
University of Leeds and Leeds Teaching Hospitals NHS Trust
Dept. of Cardiology, X39
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
 ORCID ID |
0000-0002-2861-0914 |
|---|---|
| Phone | +44 (0)1133925481 |
| j.greenwood@leeds.ac.uk |
Public
Department of Cardiology
Former Ward 39
Gilbert Scott Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 3922358 |
|---|---|
| kathryn.somers@nhs.net |
Public
Leeds Institute of Cardiovascular and Metabolic Medicine
University of Leeds
Leeds
LS2 9JT
United Kingdom
| Phone | +44 (0)7921121815 |
|---|---|
| l.m.jones@leeds.ac.uk |
Study information
| Study design | Multi-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: the COVID-HEART study |
| 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(s) | 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 |
| Condition | Assessment of heart muscle damage secondary to coronavirus disease (COVID-19) in a hospitalised-recovering patient population (or those recently discharged) with raised cardiac biomarkers (troponin) |
| Intervention | Current interventions, as of 10/05/2021: 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 enroll patients with COVID-19 infection who have had an electrocardiogram (ECG ) for clinical reasons and/or a blood test that has indicated heart muscle injury (and any participant sites from WP1 that choose to participate in the main research 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 ECG 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 questionnaires 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 viral myocarditis 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 dataset of patients with acute following heart attack dataset as the reference standard (data already acquired and available). _____ Previous interventions: 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 |
| 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 study start date | 16/04/2020 |
| Overall study end date | 31/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 370 |
| Total final enrolment | 386 |
| Participant inclusion criteria | 1. Aged ≥ 18 years 2. Diagnosed with SARS-CoV-2 infection with a raised cardiac biomarker (Troponin) |
| 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 | 27/04/2021 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Great George Street
Leeds
LS1 3EX
United Kingdom
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
51 Little France Cres
Edinburgh
EH16 4SA
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE5 9RS
United Kingdom
Sydney Street
London
SW3 6NP
United Kingdom
Polwarth Building
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Liverpool
L14 3PE
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Barrack Rd
Exeter
EX2 5DW
United Kingdom
235 Euston Road
Bloomsbury
London
NW1 2BU
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Du Cane Road
London
W12 0HS
United Kingdom
Sydney Street
London
SW3 6NP
United Kingdom
Newcastle
NE7 7DN
United Kingdom
Cranmer Terrace
Tooting
London
SW17 ORE
United Kingdom
Lower Lane
Liverpool
L9 7AL
United Kingdom
Heol Maes Eglwys
Swansea
SA6 6NL
United Kingdom
Lewisham High Street
London
SE13 6LH
United Kingdom
Sponsor information
University/education
Faculty Research Office
Room 9.29, Level 9
Worsley Building
Leeds
LS2 9NL
England
United Kingdom
| Phone | +44 (0)1133437587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 10/06/2021 | 14/06/2021 | Yes | No | |
| Results article | 27/01/2023 | 30/01/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 14/08/2024 | 02/09/2024 | Yes | No |
Editorial Notes
02/09/2024: Publication reference added.
30/01/2023: Publication reference added.
25/07/2022: The following changes have been made:
1. The intention to publish date has been changed from 31/07/2022 to 31/07/2023.
2. The final enrolment number has been added.
14/06/2021: Publication reference added.
10/05/2021: The following changes were made to the trial record:
1. The condition was changed from "Assessment of heart muscle damage secondary to coronavirus disease (COVID-19)" to "Assessment of heart muscle damage secondary to coronavirus disease (COVID-19) in a hospitalised-recovering patient population (or those recently discharged) with raised cardiac biomarkers (troponin)".
2. The interventions were changed.
3. The recruitment end date was changed from 31/07/2021 to 27/04/2021.
4. The trial participating centres University College Hospital, North Tyneside Hospital, Hammersmith Hospital, Royal Brompton Hospital, Freeman Hospital, St George’s University of London Hospital, Aintree University Hospital, Morriston Hospital, University Hospital Lewisham were added.
5. The plain English summary was updated.
06/08/2020: Internal review.
04/08/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).
