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

NCT06534151 | Not Yet Recruiting

• 1 other identifier: 173420
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart failure with reduced ejection fraction; Cardiac resynchronisation therapy; Digital twin

Outcome Measures

Primary Outcomes (5)

• Ejection fraction measured by 3-dimensional echocardiography

  An ultrasound of the heart that measures how well the heart muscle is contracting.

  3 months

• 6-minute step/walk test

  An assessment of how may steps a patient can take in 6 minutes

  3 months

• 6-minute step test

  An assessment of how may steps a patient can take in 6 minutes

  6 months

• Ejection fraction measured by 3-dimensional echocardiography

  An ultrasound of the heart that measures how well the heart muscle is contracting.

  6 months

• Blood test

  Blood test to measure N-terminal pro-brain natriuretic peptide level which is related to heart failure severity.

  6 months

Study Arms (1)

Patients undergoing implantation of cardiac resynchronisation therapy (CRT) device

These patients will have a diagnosis of heart failure with reduced ejection fraction (confirmed by a heart scan called an echocardiogram). A consultant cardiologist will advise they have a CRT device implanted to improve their symptoms and quality of life.

Device: CRT implantation

Interventions

CRT implantation DEVICE

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

Patients undergoing implantation of cardiac resynchronisation therapy (CRT) device

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will a known diagnosis of heart failure with reduced ejection fraction (seen on echocardiogram) and ventricular dyssynchrony (seen on ECG) who are symptomatic despite medical treatment, so meet criteria to have a CRT device fitted as per guidelines.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hospital NHS Trust (RFH)

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will undergo immediate laboratory testing for haematocrit and renal function (point of care testing). Other blood samples and a urine sample will be stored for later proteomics (including where applicable metabolomics and lipidomics and other small molecule analysis) and gene code analysis (DNA/RNA). The investigators may look at all or part of the DNA code, even if it has been looked at before, and at the RNA code (RNA is the version of the DNA code that the body uses to make proteins). Blood cells will be collected for future derivation of human pluripotent cells.

Central Study Contacts

Gabriella Captur

CONTACT

gabriella.captur@ucl.ac.uk

Debbie Falconer

CONTACT

07984548291; debbie.falconer@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 2, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)