Role of Colchicine as Anti-Inflammatory Therapy in HFpEF

NCT ID: NCT06837623

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-03-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant Group/Arm

Eligible HFpEF patients with a body weight of ≥70 kg will receive colchicine 0.5 mg twice daily, while those weighing \<70 kg will receive 0.5 mg once daily, in addition to usual care for 12 weeks.

Group Type: EXPERIMENTAL

Colchicine Tablets

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Colchicine

Eligibility Criteria

Inclusion Criteria

• Adult ≥ 18 years of age, males and females.
• Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
• Symptoms and/or signs of heart failure.
• H2FPEF score ≥ 6 points or HFA-PEFF score ≥ 5 points.
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥125 pg/mL at baseline (patients with atrial fibrillation at baseline NT-proBNP ≥365 pg/mL), or objective evidence of systemic or pulmonary congestion.
• Stable medical therapy within the last 1 month.

Exclusion Criteria

• Patients requiring colchicine for other conditions or with a history of colchicine intolerance or hypersensitivity.
• Active or chronic inflammatory diseases or infection.
• Presence of active solid tumors or hematological malignancies.
• Estimated glomerular filtration rate (eGFR) <35 mL/min/1.73 m².
• Severe liver disease includes Child-Pugh class B or C, cirrhosis, or chronic active hepatitis.
• Concurrent use of strong CYP3A4 or P-glycoprotein inhibitors.
• Presence of blood dyscrasias.
• Recent major cardiovascular events or procedures within the last 3 months.
• Established diagnosis of pericardial disease, myocarditis, hypertrophic cardiomyopathy, and cardiac amyloidosis
• Significant valvular heart disease.
• Lack of informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaima Mohammed Zeyad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magdy Abdelhamid Abdel Aziz, Professor of Cardivascular M

Role: STUDY_CHAIR

Cairo University

Ahmed Kamal, MD in Cardiology

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Nesrine M El Gharbawi, Prof of clin. & Chem Patho

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Shaima M Zeyad, Cardiology Resident

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University - Kasr Al-Ainy

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

ms-220-2024

Identifier Type: -

Identifier Source: org_study_id