Evaluation Effects of Colchicine and Empagliflozin in with Reduced Ejection Fraction following MI: A Randomized Double-blind Placebo-controlled Trial

Evaluation Effects of Colchicine and Empagliflozin in Reduced Ejection Fraction following MI

Clinical trial with control group, with parallel group design, not blind, randomized, phase 3, with a sample size of 96 patients. Randomization was performed using block randomization method by an independent person.

This is a randomized clinical trial on a total of 96 patients over 18 years with heart failure with reduced ejection fraction who attended the Shahid Madani clinic of Tabriz University of Medical Science. Patients in 2 intervention and one control groups will receive empagliflozin and colchicine. Patients will be compared regarding serum level of hs-CRP, NYHA Functional Classification, serum level of TNF alpha, and ejection fraction in three groups using SPSS by appropriate statistical tests (before starting treatment and one month later and three months later). .

Inclusion criteria: 1. Heart Failure with Reduced Ejection Fraction 2. Aged 18 to 80 years 3. Consented patients. Exclusion criteria: 1. Pregnancy 2. Lactation 3. Liver failure 4. Kidney failure 5. Contraindications of colchicine or empagliflozin 6. Systolic blood pressure less than 100 or more than 180 mm Hg 7. Symptomatic hypotension 8. Autoinflammatory diseases 9. Malignancy 10. Diabetes mellitus

In intervention group 1, patients will receive 25 mg of empagliflozin daily for three months with standard treatments. In intervention group 2, patients will receive 1 mg of colchicine and 10 mg of empagliflozin daily for three months with standard treatments. In control group, Patients will receive 10 mg empagliflozin daily for three months with standard treatments.

1. hs-CRP 2. NYHA Functional Classification 3.TNF alpha 4. Ejection fraction

Considering that the study will start on 2 February 9, 2023, the approximate start time of the study was changed. Considering that the classification of the New York Heart Association, which is a subjective finding, will be used to evaluate patients' heart failure, the blinding process of participants and health-care providers have been explained.

Randomization will be carried out using random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization method with random block size 6 and 9.

Participants and health care providers are not aware of the type of grouping of patients, and the study drug will be unrecognizable to patients and related treatment staff. A matched placebo is identical to colchicine in every aspect, such as appearance, smell, and taste. The only person who will know the type of drug is the coordinator of the study.

All of the data of an article can be published after making patients unrecognized.

After publishing of article until 6 months after publishing of the results

Data will be available to researchers working in academic and scientific institutions.

Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims.

Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki.

After contacting with corresponding author(Dr.Taher Entezari Maleki), data will be sent to Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be send to applicants.