Assessment of anti-inflammatory treatment with colchicine in patients with chronic heart failure with reduced left ventricular ejection fraction

Evaluation of the effect of adding colchicine to the standard treatment regimen of HFrEF in reducing inflammatory biomarkers and improving functional capacity

A controlled clinical trial , parallel-group, triple-blind, randomized, single-phase for randomization by randomization site

A study in which patients with HF in Ghaem Hospital are included in the study. After obtaining the written consent, the patients are randomly treated with the standard drug regimen of HF plus colchicine or placebo. Inflammatory markers and functional capacity of patients is measured based at the beginning of the study, and ultra-specialized echocardiography is performed in terms of left ventricular systolic and diastolic function and left atrial strain.Patients are treated with 0.5 mg oral colchicine daily. After 4 weeks from the start of taking the drug, the patients are again monitored in terms of clinical conditions in person by a cardiologist. After the end of 12 weeks of treatment, they are measured again. There are three types of blinding including: people under study, evaluator, analysts, allocation of sample data to groups

Ischemic and non-ischemic HFrEF(<40%) patients treated with standard HF drug regimen Exclusion criteria: any acute cardiac event, inflammatory and infectious disease, cancer

Intervention group: ischemic and non-ischemic HFrEF(<40%) patients who are treated with standard HF drug regimen plus colchicine Control group: ischemic and non-ischemic HFrEF(<40%) patients who are treated with standard HF drug regimen plus placebo

plasma level (hs-CRP, Interleukin 6 , pro-BNP, uric acid) NIHA functional class, CBC Echocardiographic markers of left ventricular diastolic function , left atrial strain, 6MWT, hospitalization due to HF

The volume of each block will be 4. Then write the list of blocks and assign numbers to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 16 blocks according to the sample size of 64 people. Then choosing random numbers between 1 and 16 according to the randomization site Randomaization.com and finally specifying the treatment list based on the random numbers

Using sealed and waxed opaque envelopes To explain, due to the use of placebo similar to the intervention treatment, the doctor related to the participants and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals the code A and B.