Role of Colchicine as Anti-Inflammatory Therapy in HFpEF

NCT06837623 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: ms-220-2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

HFpEF; Colchicine

Outcome Measures

Primary Outcomes (1)

• Change in Soluble Suppression of Tumourigenicity 2 (sST2,ng/ml)

  Delta\_circulating sST2

  From baseline to 12 weeks post-treatment initiation

Secondary Outcomes (2)

• Change in high-sensitivity C-reactive protein (hsCRP, mg/L)

  From baseline to 12 weeks post-treatment initiation

• Change in 6 Minute Walk Test (6MWT,meters)

  From baseline to 12 weeks post-treatment initiation

Study Arms (1)

Participant Group/Arm

EXPERIMENTAL

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.

Drug: Colchicine Tablets

Interventions

Colchicine Tablets 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

Also known as: Colchicine

Participant Group/Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University - Kasr Al-Ainy

Cairo, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Magdy Abdelhamid Abdel Aziz, Professor of Cardivascular M

  Cairo University

  STUDY CHAIR

• Ahmed Kamal, MD in Cardiology

  Cairo University

  PRINCIPAL INVESTIGATOR

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

  Cairo University

  PRINCIPAL INVESTIGATOR

• Shaima M Zeyad, Cardiology Resident

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: July 1, 2024
• Primary Completion: February 22, 2025
• Study Completion: March 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

EG (1)