The effect of different doses of empagliflozin on quality of life, heart function, atherosclerosis, vascular inflammation, blood pressure and lipid profile in non-diabetic patients with heart failure

Determining the effect of different doses of empagliflozin on quality of life, heart function, atherosclerosis, vascular inflammation, blood pressure and lipid profile in non-diabetic patients with heart failure

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 300 patients. To randomize the table of random numbers and use Sequentially numbered, sealed, opaque envelopes

This clinical trial will be performed in Professor Kojuri Cardiology clinic. major advanced cardiovascular event , side effect of medication , kcsq -12 quality of life score , NYHA functiona class, Ejectionfraction (EF), End-systolic dimention, six min walk test, Hba1c, Hematocrit(HCT), BMI, Urine analysis (U/A), Blood pressure(BP), Blood sugar (BS) , CRP-Hs, Cr / BUN, and their base level are measured.

Inclusion criteria:1) Patients with heart failure over eighteen years Exclusion criteria:1) Diabetic patients,2) Patients with an estimated glomerular filtration rate of less than 30 ml / min / 1.73 m2 (according to the diet modification in the kidney disease equation) in screening or implementation,

After screening the patients by the researcher and having the conditions to enter and obtain informed consent by Concealed allocation method, a group consisting of 100 people is given 10 mg of empagliflozin every day for one year. A group of 100 people is given 25 mg of empagliflozin every day. One number is given for one year and a group of patients including 100 placebo is given one number every day for one year.major advanced cardiovascular event is considered as primary endpoint and will compare between groups.

Quality of life; Cardiac function; Atherosclerosis; Blood pressure; lipid profile; Blood sugar; Medication side effects; Heart failure

First, 300 people are selected from the eligible ones by Simple random sampling method and it is determined by the table of random numbers whether each person is in the treatment group or not. Then 300 envelopes with aluminum foil (in order not to clarify the contents of the envelopes) are prepared, and each of the random requests created is recorded on a card and the cards are placed inside the envelope. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface of the envelopes. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively.

In this clinical trial, neither participants nor researchers knew which treatment (which dose of empagliflozin) the participants were receiving by the end of the clinical trial.