Coronary Artery Disease Clinical Trial
Official title:
The Effect of Metformin on Clinical Course of Ischemic Etiology Chronic Heart Failure in Patients With Prediabetes: the Open-label Randomized Clinical Trial
It is well known fact, that prediabetes is a predictor of high cardiovascular mortality,
increasing the risk of developing such adverse cardiovascular events as myocardial
infarction, stroke and sudden cardiac death. The key pathogenetic link in development of
carbohydrates metabolism disorders (CMD) is insulin resistance (IR), which is one of the
crucial mechanisms for the development and progression of chronic heart failure (CHF). IR
disrupts the functioning of the myocardium due to endothelial dysfunction, inflammation,
oxidative stress, remodeling and impaired myocardial metabolism. In condition of a
combination of CMD and CHF the reverse development of hyperglycemia is also difficult due to
hyperactivation of neurohormonal systems - renin-angiotensin-aldosterone system, in
particular.
So, drug therapy should neutralize the undesirable metabolic effects of hyperglycemia on the
course of CHF, as well as prevent the development of micro- and macrovascular complications.
The study will investigate the ability of metformin to impact on clinical and laboratory
(neurohormonal, lipid profiles, renal function) parameters of ischemic etiology heart failure
patients with prediabetes, as well as their quality of life and prognosis (incidence of
adverse cardiovascular events). These tests will be assessed at the beginning and repeated
after one year. At the end of the study we will investigate the difference between lifestyle
modification effect and metformin treatment.
The study is funded by Ministry of Education and Science of Kyrgyz Republic.
This is a single centre trial designed to investigate the benefit, if any, of 12-month
metformin 2000 mg/day treatment on clinical course of chronic heart failure in 78 patients
with coronary artery disease and impaired glucose tolerance.
Participants will be seen in three occasions: screening, baseline randomization, 6 month,
final 12 month, during which clinical and laboratory indicators will be assessed. There will
also be three telephone visits at: month 1, month 3, month 9.
At a screening visit an initial history will be performed during following informed consent.
Participants will undergo a laboratory, clinical and instrumental screening in Chronic Heart
Failure department of National Centre of cardiology and Internal Medicine named after
academician M.Mirrakhimov. Among with anthropologic and clinical data, prior to metformin
administration, blood samples were evaluated.
Participants who meet all inclusion criteria will return for the randomization during
hospitalization to either Metformin or Lifestyle modification alone.
After 6 months of observation safety indicators will be evaluated, as well as fasting and
postprandial glucose, creatinine, ECG.
In the active arm, therapy will be metformin in an initial dose of 1000 mg/day (metformin 500
mg х2/day). Participants will continue on Metformin 500 mg x2/day for 2 weeks, following
safety blood checks this dose will be increased to 2000 mg/day. If the higher dose cannot be
tolerated it will be reduced to 1000 mg/day (or stopped if not tolerated).
The target dose of Metformin at 2000 mg/day was chosen based on previous study of metformin
in nondiabetic heart failure patients with IR
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