A novel ultrasound method for heart failure detection
| ISRCTN | ISRCTN17117016 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17117016 |
| IRAS number | 248724 |
| Secondary identifying numbers | IRAS 248724, CPMS 40078 |
- Submission date
- 23/02/2022
- Registration date
- 25/03/2022
- Last edited
- 26/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims:
When the heart contracts with each heartbeat, the heart generates a wave of increased pressure and flow of blood, which also leads to an increased diameter of the artery. This wave travels down our arteries. Heart failure is a condition where the heart does not contract adequately, and the characteristics of the waves generated are therefore altered. Therefore, in theory, these waves can help us diagnose heart failure.
However, current methods for measuring waves travelling in our arteries are too invasive, cumbersome, inaccurate or expensive for everyday use. Therefore, we have developed a method using simple ultrasound that may overcome these problems. We have already demonstrated that this method works for detecting heart failure in rabbits. We now wish to test the potential of the method in people. We will be assessing the precision and accuracy of the method, and whether it can distinguish between patients with heart failure and patients without heart failure.
At present, diagnosis of heart failure is costly and time consuming, requiring echocardiography with expert clinical assessment. Our new method could be installed on existing clinical ultrasound scanners and used by non-specialists for screening, tracking responses to drugs and providing diagnostic information that cannot be obtained by echocardiography.
Who can participate?
Adults who are undergoing routine clinical transthoracic echocardiography and who are able to give informed consent can participate in this clinical trial.
For control groups, people with known arrhythmias, hypertension (except for the hypertensive control group), hyperlipidemia, aneurysm, diabetes, heart failure, or taking medication for cardiovascular conditions will not be invited to participate. Those who lack the capacity to consent will not be invited to participate.
What does the study involve?
The study involves a series of ultrasound measurements taken at the neck, at the upper arm and at the wrist over no more than thirty minutes. Patients will also undergo ECG monitoring, and blood pressure recordings will also be taken at the upper arm. All measurements will be taken whilst participants are reclining on a medical bed.
What are the possible benefits and risks of participating?
There are potential benefits in being able to participate in clinical research, perhaps particularly so for people with heart failure, which is a largely chronic and unremitting disease.
There is a potential that clinically significant disease such as carotid artery stenosis may be suggested by the ultrasound scans. If this possibility is raised then the participants will be informed and the research team will communicate with the participant’s clinical team (for example the participant’s GP). This possibility is described in the participant information sheet.
Where is the study run from?
Imperial College Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
August 2019 to August 2024
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Dr Anenta Ramakrishnan, ar203@ic.ac.uk
Prof. Peter Weinberg, p.weinberg@imperial.ac.uk
Contact information
Scientific
9th Floor Michael Uren Building
White City Campus
Imperial College London
London
W12 7TA
United Kingdom
 ORCID ID |
0000-0002-1467-3578 |
|---|---|
| Phone | +44 (0)20 7594 1517 |
| ar203@ic.ac.uk |
Principal Investigator
Royal School of Mines
South Kensington Campus
Imperial College London
Exhibition Road
London
SW7 2AZ
United Kingdom
| ORCID ID |
0000-0001-6114-5498 |
|---|---|
| Phone | +44 (0)20 7594 1517 |
| p.weinberg@imperial.ac.uk |
Study information
| Study design | Single-centre observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Arterial pulse waves in heart failure |
| Study acronym | Arteriowave |
| Study objectives | Our hypothesis is that our novel ultrasound-based methodology for wave intensity analysis can be performed on human participants reliably and with reproducibility, and that wave intenisty will be reduced in participants with heart failure with reduced ejection fraction. |
| Ethics approval(s) | Approved 05/12/2018, South Central - Hampshire B Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 207 1048055; hampshireb.rec@hra.nhs.uk), ref: 18/SC/0563 |
| Health condition(s) or problem(s) studied | Heart failure or those with left ventricular diastolic dysfunction but without clinical symptoms or signs of heart failure |
| Intervention | Measurements are taken on one occasion. Non-invasive ultrasound measurements will be performed on participants with ECG monitoring. Measurements at the radial, brachial and carotid artery will be attempted. Blood pressure recordings from each participant will be recorded using a peripheral brachial arm blood pressure cuff. Subsequently, analysis of ultrasound measurements will be compared to transthoracic echocardiograms that have been previously performed on participants. |
| Intervention type | Other |
| Primary outcome measure | At a single time point: 1. Wave intensity metrics obtained from non-invasive ultrasound measurements taken from the carotid, brachial and radial arteries using a range of ultrasound scanners (At present, a research ultrafast scanner is used.) 2. Routinely collected transthoracic echocardiography data using patient records. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 02/08/2019 |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 148 |
| Key inclusion criteria | Healthy volunteers: 1. Members of staff who are clinically well Patients: 1. Patients with heart failure and left ventricular systolic impairment (ejection fraction, measured by biplane Simpsons methodology on echocardiography, <40%) 2. Patients with heart failure and preserved left ventricular systolic function (ejection fraction >50%) 3. Patients without clinical symptoms or signs of heart failure but with left ventricular diastolic dysfunction with an E/E’ ratio of 15+ |
| Key exclusion criteria | 1. Known arrhythmias 2. Hypertension (except for the hypertensive control group) 3. Hyperlipidemia 4. Aneurysm 5. Diabetes 6. Heart failure 7. Taking medication for cardiovascular conditions 8. Lack capacity to consent |
| Date of first enrolment | 12/11/2019 |
| Date of final enrolment | 06/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiovascular Offices, B Block, 2nd Floor
Du Cane Road
London
W12 0HS
United Kingdom
Sponsor information
Hospital/treatment centre
Cardiology
Hammersmith Hospital
London
W120HS
England
United Kingdom
| Phone | +44 20 3313 1000 |
|---|---|
| e.magnusson@imperial.ac.uk | |
| Website | http://www.imperial.nhs.uk/ |
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed clinical medicine orientated journal. |
| IPD sharing plan | Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request please contact Anenta Ramakrishnan at a.ramakrishnan@nhs.net |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/07/2023: The overall study end date has been changed from 06/02/2022 to 31/08/2024 and the plain English summary was updated accordingly.
01/04/2022: The sponsor email has been updated.
01/04/2022: added CPMS number to Protocol/serial number field.
24/02/2022: Trial's existence confirmed by South Central - Hampshire B Research Ethics Committee
