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IRCT20250421065417N1 IRCT 2025-05-25 Qazvin University of Medical Sciences Evaluation the effect of Colchicine on quality of life in patients with acute heart failure Evaluation of Colchicin effects on the quality of life and clinical evidence in patients with acute Decompensated heart failure 2025-05-10 anticipated 70 Complete https://irct.ir/trial/83122 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Acute decompensated heart failure. Intervention 1: Intervention group: Initial dose (loading) of 2 mg of colchicine (manufactured by Darou Pakhsh Company, Tehran, Iran) is received at the time of emergency admission and then a maintenance dose of 0.5 mg twice daily for 8 weeks. For patients older than 75 years, weighing less than 70 kg, and GFR less than 50, the dose is reduced and colchicine is prescribed as a maintenance dose of 1.5 mg and 0.5 mg daily for 8 weeks. Intervention 2: Control group: They receive a placebo (with lactose) pill at the time of emergency room visit and then twice a day for 8 weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Access period starts 6 months after the results are published Conditions: Academic and scientific researchers and Industries Where to obtain: Submit request via email motamedielahe971@gmail.com How to obtain: If the applicant submits a request, if 6 months have passed since the publication of the article, it will be answered in less than 1 week. Comments:
public Elahe Motamedi
Bouali Hospital, Bouali Street
qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 motamedielahe972@gmail.com Qazvin University of Medical Sciences scientific Elahe Motamedi
Bouali Hospital, Bouali Street
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 motamedielahe972@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Acute heart failure based on signs and symptoms and echo in the emergency room Presence of clinical and radiological evidence of congestion 18 years 80 years Both Inflammatory bowel disease, chronic diarrhea, or malabsorption disease severe gastrointestinal illness Peptic ulcer Rheumatic inflammatory disease Neuromuscular disease Hematological disease Severe and recurrent arrhythmia Cirrhosis or active, chronic liver disease Patients currently taking Colchicine for another indication Severe valvular heart disease COPD GFR < 30 Hypersensitivity to colchicine Chronic treatment with Immunosuppressive drugs, steroids, or IL1 antagonists Pregnancy or breastfeeding Life expectancy less than 6 months I50.21 Acute systolic (congestive) heart failure Treatment - Drugs Placebo Intervention group: Initial dose (loading) of 2 mg of colchicine (manufactured by Darou Pakhsh Company, Tehran, Iran) is received at the time of emergency admission and then a maintenance dose of 0.5 mg twice daily for 8 weeks. For patients older than 75 years, weighing less than 70 kg, and GFR less than 50, the dose is reduced and colchicine is prescribed as a maintenance dose of 1.5 mg and 0.5 mg daily for 8 weeks. Control group: They receive a placebo (with lactose) pill at the time of emergency room visit and then twice a day for 8 weeks. The quality of life. Timepoint: Upon discharge - two months after discharge. Method of measurement: McNew Quality of Life Questionnaire. Qazvin University of Medical Sciences Approved 2025-04-20 Ethics Committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Shahid Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)