Virtual Twins and Tools for Personalised Clinical Care- the Heart Failure With Reduced Ejection Fraction Sub-study
Trial ID: NCT06534151
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-10-01
Completion date: 2028-12-31
Sponsor: University College, London
Conditions: Heart Failure With Reduced Ejection Fraction
Interventions: CRT implantation
Locations: Royal Free Hospital NHS Trust (RFH)
Countries: United Kingdom
Enrollment: 30
Age range: 19 Years - 100 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* Age: \>18 years old
* Confirmed indication for CRT-device implantation (heart failure with reduced ejection fraction and dyssynchrony on ECG)

Exclusion criteria:

* Pregnancy
* Any typical contra-indication to a MRI scan (e.g. ferromagnetic fragments in the body
* Chronic kidney disease stage 4 or 5)
* 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
* Recent myocardial infarction within 3 months
* Cardiac revascularisation or valve surgery/ implantation within the last 3 months
* Participation in a trial that includes active treatment
* Anyone with untreated symptomatic cardiovascular disease or severe hypertension

Outcomes:
Ejection fraction measured by 3-dimensional echocardiography; 6-minute step/walk test; 6-minute step test; Ejection fraction measured by 3-dimensional echocardiography; Blood test