Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway. This clinical trial aims to evaluate the effectiveness of colchicine, a well-tolerated anti-inflammatory drug, in reducing inflammation in HFpEF patients. The study will assess whether colchicine lowers levels of soluble ST2 (sST2), a biomarker linked to inflammation and cardiac stress in HFpEF. Participants will take colchicine daily for three months, with blood samples collected at baseline and at the end of the study to measure changes in sST2 levels. The findings could provide new insights into the potential role of colchicine as a treatment for HFpEF.
Heart failure with preserved ejection fraction (HFpEF) is a complex condition associated with high morbidity and mortality. While its exact causes remain unclear, low-grade systemic inflammation plays a key role by promoting myocardial fibrosis and increasing heart muscle stiffness. Despite this, anti-inflammatory treatments for HFpEF remain largely unexplored. Colchicine is a well-established anti-inflammatory drug that blocks key inflammatory pathways, including inflammasome activation and the release of interleukin-1 (IL-1). It has demonstrated cardiovascular benefits in trials such as COLCOT and LoDoCo2, significantly reducing the risk of heart-related events in coronary artery disease. However, its effects in HFpEF patients are not yet known. Two important biomarkers-soluble suppression of tumorigenicity 2 (sST2) and high-sensitivity C-reactive protein (hsCRP)-are strongly linked to worse outcomes in HFpEF. Elevated sST2 reflects increased fibrosis and cardiac stress, while high hsCRP indicates systemic inflammation. Both markers are associated with more severe symptoms and a higher risk of complications. Additionally, the 6-minute walk test (6MWT) is a widely used measure of physical function and exercise capacity in heart failure patients. This single-center, prospective clinical trial aims to evaluate the effects of colchicine in HFpEF patients with elevated inflammation. Participants will receive colchicine for three months, with assessments of sST2, hsCRP, and 6MWT performance before and after treatment. Findings from this study may provide valuable insights into whether colchicine can reduce inflammation and improve functional capacity in HFpEF patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Oral colchicine tablets. The dosing regimen is as follows: * Patients weighing \>70 kg: 0.5 mg twice daily (BID) * Patients weighing ≤70 kg: 0.5 mg once daily (OD) Administered for 3 months
Cairo University - Kasr Al-Ainy
Cairo, Cairo Governorate, Egypt
Change in Soluble Suppression of Tumourigenicity 2 (sST2,ng/ml)
Delta\_circulating sST2
Time frame: From baseline to 12 weeks post-treatment initiation
Change in high-sensitivity C-reactive protein (hsCRP, mg/L)
Delta\_circulating\_hsCRP
Time frame: From baseline to 12 weeks post-treatment initiation
Change in 6 Minute Walk Test (6MWT,meters)
Change in 6MWT distance
Time frame: From baseline to 12 weeks post-treatment initiation
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