Heart failure is a growing epidemic that affects up to 500,000 individuals in Canada, with 50,000 new cases being diagnosed each year. Half of these will have HF with preserved ejection fraction (HFpEF). HFpEF has been associated with high rates of morbidity, mortality, and health care expenditures. Its pathophysiology remains poorly understood, and positive medication trial results to date have been rare. Inflammation is strongly associated with a profibrotic activation in HFpEF, which is in turn associated with the severity and prognosis of the disease. Colchicine is a potent anti-inflammatory drug which properties relate to the suppression of tubulin polymerization and inflammasome inhibition, thus reducing the production of IL-1β and IL-18. The investigators thus propose a pilot study of 6 months follow-up duration that will test the efficacy and safety of 2 dosing regimens of colchicine (vs. placebo) in patients with HFpEF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Patients meeting all inclusion criteria and no exclusion criteria will be randomly assigned to receive either colchicine (0.5mg once daily), colchicine (0.5mg twice daily) or matched placebo (1:1:1 allocation ratio), in addition to standard of care.
Patients meeting all inclusion criteria and no exclusion criteria will be randomly assigned to receive either colchicine (0.5mg once daily), colchicine (0.5mg twice daily) or matched placebo (1:1:1 allocation ratio), in addition to standard of care.
Montreal Heart Institute
Montreal, Quebec, Canada
Change in hs-CRP (C reactive protein)
The primary endpoint will be the change from baseline to 6 months in hs-CRP (mg/L), a circulating biomarker of inflammation.
Time frame: Change from baseline to 6 months in hs-CRP
Change in circulating biomarkers of hemodynamic stress
Change in circulating biomarkers of hemodynamic stress (N-terminal pro-brain natriuretic peptide (NT-proBNP, in pg/mL))
Time frame: Change from baseline to 6 months in other biomarkers
Change in circulating biomarkers of myocardial injury
Change in circulating biomarkers of myocardial injury (hs-TnT, Troponin, in ng/L)
Time frame: Change from baseline to 6 months in other biomarkers
Change in left ventricular (LV) diastolic function
Change in a combination of echocardiography-based measures assessing left ventricular (LV) diastolic function
Time frame: Change from baseline to 6 months in LV diastolic function
Change in functional status and symptoms
Change in functional status and New York Heart Association (NYHA) class
Time frame: Change from baseline to 6 months in functional status and symptoms
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