Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03791593
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2018-12-30
Brief Title:
EVOlocumab in Stable Heart Failure With Reduced Ejection Fraction of Ischemic Etiology EVO-HF Pilot
Sponsor:
Fundació Institut Germans Trias i Pujol
Organization:
Fundació Institut Germans Trias i Pujol
Study Overview
Official Title:
EVOlocumab in Stable Heart Failure With Reduced Ejection Fraction of Ischemic Etiology EVO-HF Pilot
Status:
COMPLETED
Status Verified Date:
2023-02
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:
EVO-HF
Brief Summary:
Evolocumab has been able to reduce the incidence of cardiovascular events in patients that had at least one cardiovascular risk factor 28 In patients with chronic HFrEF as we mentioned before treatment with statins is not recommended as it has not shown benefits in improving its prognosis However CAD control stands as an approach that could improve the course of the disease by preventing microlesions that further weaken the heart A recent multicenter study the BIOSTAT-CHF 3436 was performed to determine whether the PCSK9-LDLR axis could predict risk in patients with HF A multivariate analysis which included BIOSTAT risk scores LDLR and statin treatment as covariates revealed a positive linear association between PCSK9 levels and the risk of mortality and the composite endpoint death or HF-related hospitalization A similar analysis for LDLR revealed a negative association with mortality and the composite endpoint Future studies must assess whether PCSK9 inhibition will result in better outcomes in HF
There is an unmet clinical need blockade of the neurohormonal activation has provided advances in patients with HFrEF yet mortality and morbidity remain unacceptably high Approaching a strict control of lipid levels and CAD with evolocumab in stable HFrEF of ischemic ethology may represent a complementary pathophysiological pathway to reduce mortality and morbidity The burden of CAD provides a solid rationale for testing the value of evolocumab in HF patients
Therefore a pilot trial is proposed to evaluate the beneficial effect of evolocumab by surrogate biological markers before considering an event analysis study
Evolocumab reduces the risk of cardiovascular events in patients with established atherosclerotic disease so this drug could play a role in HFrEF of ischemic etiology by limiting macro- and micro-vascular coronary disease progression In HFrEF patients due to ischemic etiology there is a continuous troponin release due to persistent myocyte injury which has been associated with adverse outcomes Our hypothesis is that evolocumab may have the potential to reduce circulating hs-TnT levels as a surrogate of myocyte injury due to atheroma progression in HFrEF A positive result in this EVO-HF Pilot study may lead to the set-up of a large-scale multicenter prospective and randomized events study analyzing the role of lipid-lowering treatment by means of evolocumab in HFrEF of ischemic etiology
There is an unmet clinical need blockade of the neurohormonal activation has provided advances in patients with HFrEF yet mortality and morbidity remain unacceptably high Approaching a strict control of lipid levels and CAD with evolocumab in stable HFrEF of ischemic ethology may represent a complementary pathophysiological pathway to reduce mortality and morbidity The burden of CAD provides a solid rationale for testing the value of evolocumab in HF patients
Therefore a pilot trial is proposed to evaluate the beneficial effect of evolocumab by surrogate biological markers before considering an event analysis study
Evolocumab reduces the risk of cardiovascular events in patients with established atherosclerotic disease so this drug could play a role in HFrEF of ischemic etiology by limiting macro- and micro-vascular coronary disease progression In HFrEF patients due to ischemic etiology there is a continuous troponin release due to persistent myocyte injury which has been associated with adverse outcomes Our hypothesis is that evolocumab may have the potential to reduce circulating hs-TnT levels as a surrogate of myocyte injury due to atheroma progression in HFrEF A positive result in this EVO-HF Pilot study may lead to the set-up of a large-scale multicenter prospective and randomized events study analyzing the role of lipid-lowering treatment by means of evolocumab in HFrEF of ischemic etiology
Detailed Description:
Evolocumab has been able to reduce the incidence of cardiovascular events in patients that had at least one cardiovascular risk factor 28 In patients with chronic HFrEF as we mentioned before treatment with statins is not recommended as it has not shown benefits in improving its prognosis However CAD control stands as an approach that could improve the course of the disease by preventing microlesions that further weaken the heart A recent multicenter study the BIOSTAT-CHF 3436 was performed to determine whether the PCSK9-LDLR axis could predict risk in patients with HF A multivariate analysis which included BIOSTAT risk scores LDLR and statin treatment as covariates revealed a positive linear association between PCSK9 levels and the risk of mortality and the composite endpoint death or HF-related hospitalization A similar analysis for LDLR revealed a negative association with mortality and the composite endpoint Future studies must assess whether PCSK9 inhibition will result in better outcomes in HF
There is an unmet clinical need blockade of the neurohormonal activation has provided advances in patients with HFrEF yet mortality and morbidity remain unacceptably high Approaching a strict control of lipid levels and CAD with evolocumab in stable HFrEF of ischemic ethology may represent a complementary pathophysiological pathway to reduce mortality and morbidity The burden of CAD provides a solid rationale for testing the value of evolocumab in HF patients
Evolocumab reduces the risk of cardiovascular events in patients with established atherosclerotic disease so this drug could play a role in HFrEF of ischemic etiology by limiting macro- and micro-vascular coronary disease progression In HFrEF patients due to ischemic etiology there is a continuous troponin release due to persistent myocyte injury which has been associated with adverse outcomes Our hypothesis is that evolocumab may have the potential to reduce circulating hs-TnT levels as a surrogate of myocyte injury due to atheroma progression in HFrEF A positive result in this EVO-HF Pilot study may lead to the set-up of a large-scale multicenter prospective and randomized events study analyzing the role of lipid-lowering treatment by means of evolocumab in HFrEF of ischemic etiology
Therefore a pilot trial is proposed to evaluate the beneficial effect of evolocumab by surrogate biological markers before considering an event analysis study
There is an unmet clinical need blockade of the neurohormonal activation has provided advances in patients with HFrEF yet mortality and morbidity remain unacceptably high Approaching a strict control of lipid levels and CAD with evolocumab in stable HFrEF of ischemic ethology may represent a complementary pathophysiological pathway to reduce mortality and morbidity The burden of CAD provides a solid rationale for testing the value of evolocumab in HF patients
Evolocumab reduces the risk of cardiovascular events in patients with established atherosclerotic disease so this drug could play a role in HFrEF of ischemic etiology by limiting macro- and micro-vascular coronary disease progression In HFrEF patients due to ischemic etiology there is a continuous troponin release due to persistent myocyte injury which has been associated with adverse outcomes Our hypothesis is that evolocumab may have the potential to reduce circulating hs-TnT levels as a surrogate of myocyte injury due to atheroma progression in HFrEF A positive result in this EVO-HF Pilot study may lead to the set-up of a large-scale multicenter prospective and randomized events study analyzing the role of lipid-lowering treatment by means of evolocumab in HFrEF of ischemic etiology
Therefore a pilot trial is proposed to evaluate the beneficial effect of evolocumab by surrogate biological markers before considering an event analysis study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004656-30 | EUDRACT_NUMBER | None | None |