Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534151
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
VITAL - the Heart Failure With Reduced Ejection Fraction Sub-study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Twins and Tools for Personalised Clinical Care- the Heart Failure With Reduced Ejection Fraction Sub-study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients heart and blood vessels known as a digital twin can be generated using artificial intelligence These models can be used to predict a patients 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 patients 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 patients response to CRT can be accurately predicted
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 patients heart and blood vessels known as a digital twin can be generated using artificial intelligence These models can be used to predict a patients 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 patients 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 patients response to CRT can be accurately predicted
Detailed Description:
Heart failure affects over 1 million people in the United Kingdom Approximately 50 of these people have heart failure with reduced ejection fraction HFrEF a condition where the muscle of the heart does not contract properly Without treatment patients are at risk of developing fluid around the lungs and legs called oedema abnormal heart rhythms known as arrhythmias and death Treatment involves a combination of tablets but some patients show no improvement with medications When the left and right chambers of the heart are not pumping at the same time devices called cardiac resynchronisation therapy CRT can be implanted to encourage the chambers to pump together reducing symptoms and improving the patients quality of life
CRT devices consist of wires which are placed into the ventricles through the blood vessels which lead to the heart However despite an initially successful procedure over one third of patients do not show any improvement following CRT implantation Risks associated with the procedure include bleeding infection and damage to the underlying lung or heart muscle which can be life-threatening meaning a significant proportion of patients undertake these risks with no benefit afterwards Moreover the infection risk is lifelong and patients may develop device-related infective endocarditis at any stage which is associated with a high mortality
Virtual models of a patients anatomy and blood flow known as a digital twin can be generated using artificial intelligence These models can be used to predict a patients response to a treatment or procedure Digital twins have been studied in research projects looking at coronavirus disease 2019 COVID-19 asthma and cancer Within cardiology digital twins have been studied in patients who are undergo valve surgery So far no models have been developed to predict patients responses to heart failure treatments
Working closely with bioengineers physiologists and computer scientists this study aims to develop a validated multi-scale multi-organ modelling platform than can create an individualised virtual twin incorporating cardiovascular anatomy as well as complex physiological processes including the inter-connection of organ systems the autonomic nervous system activity and hormonal actions
A minimum of 30 patients who are undergoing a clinically-indicated implantation of CRT will be recruited Before the procedure each patient will attend University College London UCL for a range of tests including measurement of height weight and blood pressure an echocardiogram a cardiac magnetic resonance imaging MRI scan a 12-lead electrocardiogram ECG a 256-lead electrocardiographic imaging recording a 5-minute detailed recording of the heartbeat a 6-minute walking stepping test and blood and urine sample collection A subset of patients will also be provided with a wearable heart monitor which will be worn during their UCL appointment These data will be integrated into the modelling framework to create a personalised virtual twin for each patient
Following implantation of the CRT each patient will return for follow-up visits at 3 months and 6 months when they will undergo a further echocardiogram blood test and 6 minute stepwalk test
A clinically-validated virtual platform would have the potential to transform how patients are selected to undergo device implantation in the following ways
Patients who are predicted to be non-responders can be directed to other treatments and avoid the serious potential risks associated with device implantation
Device selection can be optimised There are 2 forms of CRT
1 Biventricular pacing BiVP which involves implanting one lead into each ventricle
2 Conduction system pacing CSP which requires placement of a lead into the conducting heart tissue in the septum between the ventricles
CSP is considered to better mimic the hearts own physiology but is more technically challenging to achieve often leading to a longer and higher risk procedure Patients referred for both forms of CRT will be recruited to this study A validated modelling platform may be able to predict which form of pacing would benefit the patient most meaning clinicians will be able to select the optimal form of pacing without exposing a patient to unnecessary complications
CRT devices consist of wires which are placed into the ventricles through the blood vessels which lead to the heart However despite an initially successful procedure over one third of patients do not show any improvement following CRT implantation Risks associated with the procedure include bleeding infection and damage to the underlying lung or heart muscle which can be life-threatening meaning a significant proportion of patients undertake these risks with no benefit afterwards Moreover the infection risk is lifelong and patients may develop device-related infective endocarditis at any stage which is associated with a high mortality
Virtual models of a patients anatomy and blood flow known as a digital twin can be generated using artificial intelligence These models can be used to predict a patients response to a treatment or procedure Digital twins have been studied in research projects looking at coronavirus disease 2019 COVID-19 asthma and cancer Within cardiology digital twins have been studied in patients who are undergo valve surgery So far no models have been developed to predict patients responses to heart failure treatments
Working closely with bioengineers physiologists and computer scientists this study aims to develop a validated multi-scale multi-organ modelling platform than can create an individualised virtual twin incorporating cardiovascular anatomy as well as complex physiological processes including the inter-connection of organ systems the autonomic nervous system activity and hormonal actions
A minimum of 30 patients who are undergoing a clinically-indicated implantation of CRT will be recruited Before the procedure each patient will attend University College London UCL for a range of tests including measurement of height weight and blood pressure an echocardiogram a cardiac magnetic resonance imaging MRI scan a 12-lead electrocardiogram ECG a 256-lead electrocardiographic imaging recording a 5-minute detailed recording of the heartbeat a 6-minute walking stepping test and blood and urine sample collection A subset of patients will also be provided with a wearable heart monitor which will be worn during their UCL appointment These data will be integrated into the modelling framework to create a personalised virtual twin for each patient
Following implantation of the CRT each patient will return for follow-up visits at 3 months and 6 months when they will undergo a further echocardiogram blood test and 6 minute stepwalk test
A clinically-validated virtual platform would have the potential to transform how patients are selected to undergo device implantation in the following ways
Patients who are predicted to be non-responders can be directed to other treatments and avoid the serious potential risks associated with device implantation
Device selection can be optimised There are 2 forms of CRT
1 Biventricular pacing BiVP which involves implanting one lead into each ventricle
2 Conduction system pacing CSP which requires placement of a lead into the conducting heart tissue in the septum between the ventricles
CSP is considered to better mimic the hearts own physiology but is more technically challenging to achieve often leading to a longer and higher risk procedure Patients referred for both forms of CRT will be recruited to this study A validated modelling platform may be able to predict which form of pacing would benefit the patient most meaning clinicians will be able to select the optimal form of pacing without exposing a patient to unnecessary complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None