Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05177588
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2021-12-16
Brief Title:
Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients
Status:
COMPLETED
Status Verified Date:
2023-07
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:
There is an increasing interest in the use of metformin in CV diseases and there is an increasing interest in studying its potential new roles in heart failure patients There were some concerns related to the safety of metformin in such diabetic patients due to the risk of lactic acidosis However recent studies showed that metformin was safe or even beneficial in HF patients We hypothesized that metformin might improve morbidity mortality cardiac function and HR-QoL in non-diabetic patients with HFrEF
Detailed Description:
Metformin is an anti-diabetic drug that is known improve insulin sensitivity and reduce insulin resistance A published meta-analysis of randomized controlled trials RCTs reported a reduction of weight and insulin resistance in metformin users Animal models also showed that metformin reduces cardiac hypertrophy Observational studies showed a beneficial effect for metformin in patients with type 2 diabetes mellitus T2DM and heart failure A recent study found that metformin reduced oxidative stress in non-diabetic patients with CAD
Metformin has multiple modes of actions involving both AMP-activated protein kinase AMPK dependent and AMPK-independent mechanisms that may be implicated in cardiac hypertrophy At the systemic level a review of clinical and experimental data showed that metformin improves endothelial function protects from oxidative stress and inflammation as well as the negative effects of angiotensin II Observational studies also reported cardiovascular benefits in metformin users especially in patients with type 2 diabetes mellitus T2DM and heart failure Metformin has also been shown to exert a cardio protective effect and it has been shown to reduce oxidative stress which is a common finding in heart failure patients For these reasons there is an increasing interest in the use of metformin in CV diseases and there is an increasing interest in studying its potential new roles in this aspect We hypothesized that metformin might improve morbidity mortality cardiac function and HR-QoL in non-diabetic patients with HFrEF
Metformin has multiple modes of actions involving both AMP-activated protein kinase AMPK dependent and AMPK-independent mechanisms that may be implicated in cardiac hypertrophy At the systemic level a review of clinical and experimental data showed that metformin improves endothelial function protects from oxidative stress and inflammation as well as the negative effects of angiotensin II Observational studies also reported cardiovascular benefits in metformin users especially in patients with type 2 diabetes mellitus T2DM and heart failure Metformin has also been shown to exert a cardio protective effect and it has been shown to reduce oxidative stress which is a common finding in heart failure patients For these reasons there is an increasing interest in the use of metformin in CV diseases and there is an increasing interest in studying its potential new roles in this aspect We hypothesized that metformin might improve morbidity mortality cardiac function and HR-QoL in non-diabetic patients with HFrEF
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?:
False
Is an FDA AA801 Violation?:
None