NCT06837623

Role of Colchicine as Anti-Inflammatory Therapy in HFpEF

The Role of Colchicine as Anti-Inflammatory Treatment in Patients With HFpEF: A Prospective Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HFpEF - Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	Colchicine Tablets	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

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-02-22
• Completion: 2025-03-01
• First posted: 2025-02-20
• Last updated: 2025-02-25

Locations

1 site across 1 country: Egypt