VITAL-HFrEF
Research type
Research Study
Full title
Virtual twins and tools for personalised clinical care- the heart failure with reduced ejection fraction substudy.
IRAS ID
341586
Contact name
Gabriella Captur
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2024/04/49, Data protection number from UCL
Duration of Study in the UK
4 years, 1 months, 31 days
Research summary
Heart failure affects over 1 million people in the United Kingdom. Approximately 50% have heart failure with reduced ejection fraction (HFrEF), when the heart muscle does not contract well. If the right and left chambers (ventricles) of the heart are not pumping synchronously, devices called cardiac resynchronisation therapy (CRT) can be implanted to encourage the ventricles to pump together, reducing heart failure symptoms.
CRT devices consist of leads which are placed into the ventricles through the blood vessels that enter the heart. However, over one third of patients do not show any improvement in symptoms following CRT implantation, and another third show only a partial improvement. We cannot accurately predict who will respond well, meaning patients may undergo a procedure with no benefit, being exposed to risks including bleeding and infection.
Virtual models of a patient's anatomy and blood flow, known as a ‘digital twin', can be generated using artificial intelligence. These models can be used to predict the response to a treatment or procedure, without the patient having to undergo the procedure first, reducing unnecessary exposure to risks.
30 patients with HFrEF who have been previously selected to have CRT implanted by a consultant cardiologist (either standard CRT known as biventricular pacing with 2 leads, or conduction system pacing with one lead) will be recruited. For each patient, data from blood tests, a wearable heart monitor, heart ultrasound scan, cardiac MRI scan and a 5-minute recording of the heartbeat will be combined to create a 'digital twin'.
The patient’s response to CRT will be measured by assessing their symptoms (during a 6-minute stepping test) and performing a heart ultrasound scan after the procedure to determine if we can use the digital models to better predict which patients will respond best to CRT, allowing clinicians to identify which patients will benefit most.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0197
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion