A Phase 4 interventional study of Metformin Hydrochloride in Heart Failure, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 70 is close to the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Diabetes mellitus: Diabetes will be diagnosed using the 2018 The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes 15
Patients in the metformin group will receive a starting dose of 1000 mg/day. The dose will be titrated as tolerated to a maximum of 2000 mg/. Patients will receive the medications for six year and will be followed up for the duration of the study. Patients will be assessed at baseline, 3 months, and 6 months.
Drug: Metformin Hydrochloride
Patients in the control arm will continue the SOC medications
Metformin 2000 mg/day
Also known as: Glucophage, Cidophage
Change in total antioxidant capacity (relative and absolute)
Change Total antioxidant capacity as assessed by colorimetric assay
Time frame: 6 months
Change in Malondialdehyde (MDA)
Change in Malondialdehyde (MDA) as assessed by colorimetric assay
Time frame: 6 months
Chagne in left ventricular mass index
Chagne in left ventricular mass index as assessed by Echocardiography
Time frame: 6 months
Chagne in Ejection Fraction
Ejection fraction as assessed by echocardiography
Time frame: 6 months
New York Heart Association functional classification (NYHA):
The NYHA classifies patients in one of four possible categories based on the physical activity limitations; the limitations/symptoms are in regards to normal breathing andvarying degrees in shortness of breath and or angina pain
Time frame: 6 months
TAC
Total antioxidant capacity as assessed by colorimetric assay
Time frame: 6 months
MDA
MDA as assessed by colorimetric assay
Time frame: 6 months
Adverse reactions of metformin
Incidence of lactic acidosis
Time frame: 6 months
Change in fasting blood glucose (FBG)
Change in FBG from baseline
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin