Health Condition 1: I501- Left ventricular failure, unspecified
Conditions
Interventions
Intervention1: Colchicine: Dose: 0.5 mg
Frequency: Once a day
Route of administration: Oral
Total duration of such intervention: 45 months
Control Intervention1: Placebo: Placebos will be manufactured
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years and above with HFrEF less than or equal to 40 percentage in New York Heart Association NYHA class II to IV ambulatory symptoms with any one or more of the following criteria 1. Elevated BNP or NTproBNP concentrations within the last 3 months For sinus rhythm: NTproBNP greater than or equal to 1000 pg per mL or BNP greater than or equal to 300 pg per mL. For atrial fibrillation, NTproBNP greater than or equal to 1600 pg per mL or BNP greater than or equal to 500 pg per mL or recent hospitalization for HF within the last 3 months. 2. Among diagnosed patients with HF, unplanned, recurrent inpatient or outpatient visits for worsening symptoms or signs of HF. 3. Patients hospitalized for new onset acute heart failure and who are, off inotropic support for more than 24 hours, and without any evidence of sepsis as confirmed by the site principal investigators.
Exclusion criteria
Exclusion criteria: 1. History or evidence of severe valvular heart disease with an indication for surgery 2. Patients planned for elective PCI or CABG or who underwent PCI or CABG in the last three months 3. Prior heart transplantation 4. Patients with cardiogenic shock on inotropic support 5. Life expectancy of less than1 year, as determined by the treating physician 6. History of gastrointestinal disorders, including inflammatory bowel disease, chronic diarrhoea, malabsorptive disease, or any other severe documented gastrointestinal diseases 7. Neuromuscular diseases 8. Haematologic diseases 9. Cirrhosis, chronic active hepatitis 10. Prior or current malignancy 11. Chronic or recurrent infectious diseases, including hepatitis B, hepatitis C, and HIV or AIDS. 12. Chronic treatment with immunosuppressants, steroids, or IL1 antagonists in the past 6 months 13. Currently taking colchicine for other indications including, but not limited to, gout, familial Mediterranean fever, coronary artery disease, or pericarditis 14. Known history of allergic reaction or hypersensitivity to colchicine 15. Severe renal impairment with eGFR less than 30 ml per min per 1.73 sq.m 16. Women who are pregnant or breastfeeding women 17. Women who are planning pregnancy 18. No known/concomitant participation in any other randomized controlled trial 19. Patients unwilling or unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the efficacy and safety of colchicine 0.5 mg per day in reducing the risk of a composite of all cause mortality, all cause hospitalization, or worsening of heart failure compared to placebo, over an anticipated 35 month median follow up period. The primary endpoint is the time from randomization to first occurrence of a composite of all cause death, all cause hospitalization, or worsening of heart failure between the placebo and colchicine armsTimepoint: Baseline to 45th month | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to occurrence of individual components of primary outcome 1. All Cause mortality 2. All Cause Hospitalization 3. Worsening of heart failure including hospitalization for heart failure, emergency or outpatient visits requiring intravenous furosemide, or outpatient visits requiring an increased dose of oral diureticsTimepoint: Baseline to 45th month;Change from baseline in exercise capacity as measured by the 6 minute walk test 6MWTTimepoint: Baseline to 45th month;Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire KCCQ clinical summary scoreTimepoint: Baseline to 45th month;Change from baseline in quality of life as measured by the EQ 5D 5LTimepoint: Baseline to 45th month;Subgroup analysis by various sub-groups Age, gender, ICM (LV function less than 40% with prior history of CAD/MI/PCI/CABG or ECG evidence of Q-wave/Echocardiographic evidence of regional wall motion abnormality/SPECT/PET/CMR/Angiographically confirmed CAD) Vs DCMP etc.Timepoint: Baseline to 45th month;Change from baseline in biomarkers such as NTproBNP & cytokines including IL 6 & IL 1beta at 3 monthsTimepoint: Baseline to 3rd month;Change from baseline in functional status, as measured by the New York Heart Association NYHA classification systemTimepoint: Baseline to 45th month | — |
Countries
India
Contacts
Public ContactDr Meena Iyer
Sri Ramachandra Hospital
Outcome results
None listed