Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443645
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-13
Brief Title:
Role of Sodium-glucose Linked Transporter 2 SGLT2 and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
Official Title:
Role of Sodium-glucose Linked Transporter 2 SGLT2 and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis - SCARA-B
Status:
NOT_YET_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:
SCARA-B
Brief Summary:
In the context of breast cancer in case of an indication for chemotherapy anthracycline-based protocols make it possible to improve the overall survival of patients most at risk The frequency of anthracycline-related cardiac toxicities ARCT increases with the cumulative dose of anthracyclines administered and explains at least in part the increased risk of cardiovascular CV mortality in patient populations treated for breast cancer The numerous indications for anthracycline-based protocols have made it possible to describe ARCT among which heart failure with reduced left ventricular ejection fraction LVEF remains one of the most comorbid In addition to left ventricular dysfunction anthracyclines have been associated with endothelial dysfunction microvascular damage and myocardial ischemia responsible for dilated cardiomyopathy
Different approaches have attempted to better understand and prevent these ARCT However apart from the notion of limit cumulative doses of anthracyclines few of them have made it possible to screen patients at risk and prevent the onset of cardiac dysfunction The search for biological markers Troponin I BNP or ultrasound markers Longitudinal Strain warning of subclinical cardiac damage is still struggling to assert its interest due in particular to significant inter- and intra-observer variability Therapeutically ACE inhibitors and beta-blockers have shown a significant improvement in the incidence rate of LVEF reduction during adjuvant treatment of breast cancer However despite equivalent signals in other cancers the studies conducted to date are insufficiently powered and the role of these treatments is limited to secondary prevention or the treatment of objective heart failure It remains necessary to determine new biological markers that can identify patients most at risk of ARCT and thus adapt our therapeutic prevention strategies To do this it is first necessary to better understand the pathophysiology underlying these ARCT
The objective of this study is to determine whether expression of the receptor among endothelium and circulating cells SGLT2 is associated with an additional risk of presenting cardiovascular toxicity following treatment with anthracycline If this association is demonstrated it will then be possible to better screen and prevent these cardiovascular complications
Different approaches have attempted to better understand and prevent these ARCT However apart from the notion of limit cumulative doses of anthracyclines few of them have made it possible to screen patients at risk and prevent the onset of cardiac dysfunction The search for biological markers Troponin I BNP or ultrasound markers Longitudinal Strain warning of subclinical cardiac damage is still struggling to assert its interest due in particular to significant inter- and intra-observer variability Therapeutically ACE inhibitors and beta-blockers have shown a significant improvement in the incidence rate of LVEF reduction during adjuvant treatment of breast cancer However despite equivalent signals in other cancers the studies conducted to date are insufficiently powered and the role of these treatments is limited to secondary prevention or the treatment of objective heart failure It remains necessary to determine new biological markers that can identify patients most at risk of ARCT and thus adapt our therapeutic prevention strategies To do this it is first necessary to better understand the pathophysiology underlying these ARCT
The objective of this study is to determine whether expression of the receptor among endothelium and circulating cells SGLT2 is associated with an additional risk of presenting cardiovascular toxicity following treatment with anthracycline If this association is demonstrated it will then be possible to better screen and prevent these cardiovascular complications
Detailed Description:
None
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