Tests computer heart models to predict response to heart device
Studies whether computer models predict benefit from a heart device in adults with heart failure.
Plain-language title generated from the registry record
Registry title: VITAL - the Heart Failure With Reduced Ejection Fraction Sub-study
Key facts
- Where
- London, United KingdomSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 100 years old?
Source: NCT06534151, who can take part
Where in United Kingdom
- Royal Free Hospital NHS Trust (RFH)London, United KingdomNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University College, London
- Trial code
- NCT06534151
- Record updated
- 2 August 2024
- Original description
Heart failure affects over 1 million people in the United Kingdom. Approximately 50% have heart failure with reduced ejection fraction (HFrEF), a condition where the heart muscle does not contract properly. If the right and left chambers (called 'ventricles') of the heart are not pumping at the same time, devices called cardiac resynchronisation therapy (CRT) can be inserted to encourage the ventricles to pump together, reducing heart failure symptoms and helping people to live longer.Read full original descriptionShow less
Virtual Twins and Tools for Personalised Clinical Care- the Heart Failure With Reduced Ejection Fraction Sub-study
Heart failure affects over 1 million people in the United Kingdom. Approximately 50% have heart failure with reduced ejection fraction (HFrEF), a condition where the heart muscle does not contract properly. If the right and left chambers (called 'ventricles') of the heart are not pumping at the same time, devices called cardiac resynchronisation therapy (CRT) can be inserted to encourage the ventricles to pump together, reducing heart failure symptoms and helping people to live longer.
CRT devices are made of wires which are placed into the ventricles through the blood vessels that carry blood to and from the heart. However, one third of patients do not show any improvement following CRT insertion, and another third show only a partial improvement. Doctors 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 heart and blood vessels, known as a 'digital twin', can be generated using artificial intelligence. These models can be used to predict a patient's response to a procedure without them having to undergo the procedure first, meaning patients can avoid being exposed to risks.
30 patients with HFrEF who have been selected to have CRT implanted by their consultant cardiologist will be recruited. Before having their procedure patients will attend University College London (UCL) for tests including a blood test, urine test, magnetic resonance imaging (MRI) scan of the heart, ultrasound of the heart, a 5-minute heart recording and a 6- minute walking/ stepping test. After the CRT is implanted, the patient's response to the device will be assessed with a blood test, a 6-minute walking/ stepping test and a heart ultrasound scan 3 and 6 months after the procedure. The virtual models will be used to determine if a patient's response to CRT can be accurately predicted.
Inclusion: Age: >18 years old; Confirmed indication for CRT-device implantation (heart failure with reduced ejection fraction and dyssynchrony on ECG).
Exclusion: Chronic kidney disease stage 4 or 5); Recent myocardial infarction within 3 months; Cardiac revascularisation or valve surgery/ implantation within the last 3 months; Anyone with untreated symptomatic cardiovascular disease or severe hypertension; Pregnancy; Any typical contra-indication to a MRI scan (e.g. ferromagnetic fragments in the body; Not able to mobilise (as they will not be able to participate in a 6 minute step test); Extreme frailty or life expectancy < 6 months; Participation in a trial that includes active treatment.