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Effects of Colchicine and Empagliflozin in Myocardial Dysfunction

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20111206008307N39
Enrollment
96
Registered
2022-10-27
Start date
2023-02-09
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Heart failure. Condition 2: ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction. Heart failure ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention 1: Intervention group 1: Patients will receive 25 mg of empagliflozin daily for three months with standard treatments. Intervention 2: Intervention group 2: Patients will receive 1 mg of

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Heart Failure with Reduced Ejection Fraction Aged 18 to 80 years Consented patients

Exclusion criteria

Exclusion criteria: Pregnancy Lactation Liver failure Kidney failure Contraindications of colchicine or empagliflozin Systolic blood pressure less than 100 or more than 180 mm Hg Symptomatic hypotension Autoinflammatory diseases Malignancy Diabetes mellitus

Design outcomes

Primary

MeasureTime frame
High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test.;New York Heart Association (NYHA) Functional Classification. Timepoint: At baseline and 1, and 3 months after intervention. Method of measurement: Assessment by one cardiologist.

Secondary

MeasureTime frame
Left ventricular diastolic function. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography.;Left ventricular end-diastolic diameter. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography.;Mitral valve regurgitation grade. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography.;Tumour Necrosis Factor alpha (TNF alpha). Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test.;Ejection fraction. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Echocardiography.;Total antioxidant capacity. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test.;Malondialdehyde. Timepoint: Before intervention and 1, and 3 months after intervention. Method of measurement: Laboratory test.;?Empagliflozin serum concentration. Timepoint: One and three months after intervention. Method of measurement: Laboratory test.;Left ventricular diastolic function. Timepoint: One and three months after intervention. Method of measurement: Echocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTaher Entezari-Maleki

Tabriz University of Medical Sciences

tentezari@gmail.com+98 41 3335 5983

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026