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NOT YET RECRUITING
NCT06534151

VITAL - the Heart Failure With Reduced Ejection Fraction Sub-study

Sponsor: University College, London

View on ClinicalTrials.gov

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.

Official title: Virtual Twins and Tools for Personalised Clinical Care- the Heart Failure With Reduced Ejection Fraction Sub-study

Key Details

Gender

All

Age Range

19 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2024-10-01

Completion Date

2028-12-31

Last Updated

2024-08-02

Healthy Volunteers

No

Interventions

DEVICE

CRT implantation

A CRT is a device (that looks like a pacemaker) that will be used to help the ventricles contract synchronously.

Locations (1)

Royal Free Hospital NHS Trust (RFH)

London, United Kingdom