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

NCT06534151 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DEVICE

CRT implantation

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534151 on ClinicalTrials.gov