Evaluation of Colchicin effects on the quality of life and clinical evidence in patients with acute Decompensated heart failure

Determining the effect of colchicine on quality of life in patients with acute heart failure referred to Bu Ali Hospital

This clinical trial has 2 intervention groups, Three-blinded, 70 acute heart failure patients are randomly divided into two groups using the random assignment rule. Each of these selected individuals will be assigned a numerical sequence from 1 to 70. Then, using the Statistics and Sample Size software, the random sequence will be considered for entering individuals into the study.

Patients aged 18-80 who referred to Bu-Ali-Sina Hospital in Qazvin in 2025 with acute heart failure are studied. Demographic information is recorded on the first day of hospitalization. Anti-inflammatory treatment is given in the emergency room and then in a maintenance dose for 8 weeks in one group with Colchicine and in the other group with placebo.

Inclusion criteria: acute heart failure evidence of congestion 18 and 80 years Exclusion criteria: Incomplete records and questionnaire Neuromyosarcoma,hematological,rheumatic,severe gastrointestinal disease, peptic ulcer,chronic diarrhea,malabsorption,cirrhosis or chronic liver disease and COPD Severe and recurrent arrhythmia currently taking colchicine Severe valvular heart disease GFR < 30 allergy to colchicine using immunosuppressive drugs, steroids or IL1 antagonists pregnancy and beastfeeding Non-cooperation Life expectancy less than 6 months

An initial dose of 2 mg of colchicine (manufactured by Darou Pakhsh Company, Tehran, Iran) is given at the time of emergency admission, followed by a maintenance dose of 0.5 mg twice daily for 8 weeks. For patients older than 75 years, weighing less than 70 kg, and with a GFR less than 50, the dose is reduced to 1.5 mg as a maintenance dose and 0.5 mg daily for 8 weeks.

Quality of life

To implement random allocation, creating a random sequence using the "Random Allocation Law" method will be used. Thus, after determining the sample size, among the people identified in the first stage, several people who meet the criteria for entering the study, are willing to participate in the study and sign the informed consent form, will be selected using the accessible method. In the second stage, each of these selected people will be assigned a numerical order from 1 to 70. In the third step, 70 random sequences created by Statistics and Sample Size software (random numbers without repetition between 1 and 70) will be considered to include people in the study. Each of these numbers will correspond to the number assigned to a person, which is specified in the first list of 70. The numbers will be assigned to the intervention group (prescribing Colchicine) and the control group in sequence, and this sequence will be repeated to obtain the desired number of samples for each group. How the random assignment will be performed and to which group the individual will be specialized will not be obvious to the participants.

Doctors and researchers collecting data and investigating the outcome and health care personnel will be unaware of the intervention groups. Colchicine and Placebo drugs have been prepared and will be placed in the hospital without its medicinal properties. Medication packages are prepared by a separate pharmacist. A special code for the type of drug is specified on each package, which identifies it in the study database.

All data is potentially shareable after unidentified individuals

Access period starts 6 months after the results are published

Access period starts 6 months after the results are published

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