Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469645
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-05
Brief Title:
The Role of SGLT2i in Management of Moderate AS
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
The Role of Sodium Glucose Cotransporter 2 Inhibitors in the Management of Patients With Aortic Stenosis
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
The aortic valve is like a door in the heart that lets blood flow out to the body Over time this valve can get worn out and become too narrow leading to a condition called aortic stenosis When this happens the heart has to work extra hard to push blood through the narrow valve to supply the body with what it needs This extra effort can cause the heart muscle to become abnormally thick or to have fibrosis For people with aortic stenosis this can lead to more problems like feeling out of breath chest pain and even needing to go to the hospital It also increases the risk of dying from heart issues There is a type of medication called Sodium Glucose Cotransporter 2 SGLT2 inhibitors which has been studied in people with weak heart muscle These medicines were found to help the heart work better and improve the pumping of blood around the body This can be promising for patients with aortic stenosis because it might make the heart muscle stronger and protect it from damage
Aim of research study
The aim of this study is to investigate whether the use of the drug empagliflozin an SGLT2 inhibitor prevents the formation of fibrosis or the abnormal thickening of the heart muscle in patients with aortic stenosis Using advanced imaging techniques such as echocardiography and cardiovascular magnetic resonance we intend to study their effect on the heart muscle of patients with aortic stenosis
Study design
Patients with moderate aortic stenosis will be invited for participation Eligible consenting patients will have a baseline assessment with cardiac MRI scan echocardiography cardiopulmonary exercise test and validated quality of life questionnaires They will then be randomised to receive either the SGLT2i for 6 months or standard of care All patients will undergo the same tests at 6 months This way we aim to investigate the potential changes in the heart muscle and whether the SGLT2 inhibitor prevents fibrosis or hypertrophy
The aortic valve is like a door in the heart that lets blood flow out to the body Over time this valve can get worn out and become too narrow leading to a condition called aortic stenosis When this happens the heart has to work extra hard to push blood through the narrow valve to supply the body with what it needs This extra effort can cause the heart muscle to become abnormally thick or to have fibrosis For people with aortic stenosis this can lead to more problems like feeling out of breath chest pain and even needing to go to the hospital It also increases the risk of dying from heart issues There is a type of medication called Sodium Glucose Cotransporter 2 SGLT2 inhibitors which has been studied in people with weak heart muscle These medicines were found to help the heart work better and improve the pumping of blood around the body This can be promising for patients with aortic stenosis because it might make the heart muscle stronger and protect it from damage
Aim of research study
The aim of this study is to investigate whether the use of the drug empagliflozin an SGLT2 inhibitor prevents the formation of fibrosis or the abnormal thickening of the heart muscle in patients with aortic stenosis Using advanced imaging techniques such as echocardiography and cardiovascular magnetic resonance we intend to study their effect on the heart muscle of patients with aortic stenosis
Study design
Patients with moderate aortic stenosis will be invited for participation Eligible consenting patients will have a baseline assessment with cardiac MRI scan echocardiography cardiopulmonary exercise test and validated quality of life questionnaires They will then be randomised to receive either the SGLT2i for 6 months or standard of care All patients will undergo the same tests at 6 months This way we aim to investigate the potential changes in the heart muscle and whether the SGLT2 inhibitor prevents fibrosis or hypertrophy
Detailed Description:
Background
Aortic stenosis represents one of the commonest valvular heart diseases in the Western World Studies have shown that as the valvular narrowing progresses pathological left ventricular LV hypertrophy and fibrosis develop This maladaptive left ventricular remodelling is associated with adverse events and worse long-term prognosis Currently there is no available medication to slow down or prevent these pathological processes occurring in aortic stenosis Evidence from recent large randomised controlled trials have demonstrated that SGLT2 inhibitors have a significant positive impact on quality of life and cardiovascular outcomes of patients with heart failure This is a result of complex mechanisms such as attenuation of cardiac myofibroblast activity and collagen remodelling These could be proved to be very beneficial for patients with aortic stenosis since the left ventricular pathological changes occurring in aortic stenosis share similar pathways and mechanisms with heart failure
Study aims and objectives
The aims of this study are to assess if
SGLT2 inhibitors can prevent or decelerate adverse myocardial remodelling and fibrosis
SGLT2 inhibitors can improve the exercise tolerance and functional capacity of patients with aortic stenosis
Methods
Given that the use of SGLT2 inhibitors in aortic stenosis has not been investigated before we aim to investigate the hypotheses with an early stage randomised controlled trial For this patients with moderate aortic stenosis identified in the outpatient cardiology clinic will be invited to participate Management of moderate aortic stenosis is conservative with a watchful waiting approach The participants will be randomised either to usual conservative management or to the intervention group use of SGLT2 inhibitor on top of regular medications They will be assessed at baseline and at 6-months following initiation of the medication Both appointments will include evaluation of symptoms with the use of validated questionnaire and functional capacity cardiopulmonary exercise test electrocardiogram and blood tests An echocardiogram a scan performed routinely on a yearly basis for all patients with moderate aortic stenosis will also be performed at baseline and at completion of the 6 months follow-up period to evaluate for myocardial hypertrophy and remodelling Additionally a cardiopulmonary exercise test and a cardiac magnetic resonance scan will be performed in these two timepoints to assess for myocardial remodelling and fibrosis
Aortic stenosis represents one of the commonest valvular heart diseases in the Western World Studies have shown that as the valvular narrowing progresses pathological left ventricular LV hypertrophy and fibrosis develop This maladaptive left ventricular remodelling is associated with adverse events and worse long-term prognosis Currently there is no available medication to slow down or prevent these pathological processes occurring in aortic stenosis Evidence from recent large randomised controlled trials have demonstrated that SGLT2 inhibitors have a significant positive impact on quality of life and cardiovascular outcomes of patients with heart failure This is a result of complex mechanisms such as attenuation of cardiac myofibroblast activity and collagen remodelling These could be proved to be very beneficial for patients with aortic stenosis since the left ventricular pathological changes occurring in aortic stenosis share similar pathways and mechanisms with heart failure
Study aims and objectives
The aims of this study are to assess if
SGLT2 inhibitors can prevent or decelerate adverse myocardial remodelling and fibrosis
SGLT2 inhibitors can improve the exercise tolerance and functional capacity of patients with aortic stenosis
Methods
Given that the use of SGLT2 inhibitors in aortic stenosis has not been investigated before we aim to investigate the hypotheses with an early stage randomised controlled trial For this patients with moderate aortic stenosis identified in the outpatient cardiology clinic will be invited to participate Management of moderate aortic stenosis is conservative with a watchful waiting approach The participants will be randomised either to usual conservative management or to the intervention group use of SGLT2 inhibitor on top of regular medications They will be assessed at baseline and at 6-months following initiation of the medication Both appointments will include evaluation of symptoms with the use of validated questionnaire and functional capacity cardiopulmonary exercise test electrocardiogram and blood tests An echocardiogram a scan performed routinely on a yearly basis for all patients with moderate aortic stenosis will also be performed at baseline and at completion of the 6 months follow-up period to evaluate for myocardial hypertrophy and remodelling Additionally a cardiopulmonary exercise test and a cardiac magnetic resonance scan will be performed in these two timepoints to assess for myocardial remodelling and fibrosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None