NCT06837623Active, not recruitingPhase 3
Role of Colchicine as Anti-Inflammatory Therapy in HFpEF
The Role of Colchicine as Anti-Inflammatory Treatment in Patients With HFpEF: A Prospective Study
Source: ClinicalTrials.gov · Last updated 25 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 15 Feb 2025
- Start date
- 1 Jul 2024
- Primary completion date
- 22 Feb 2025
- Lead sponsor
- Cairo University
- Diseases
- Heart failure
- NCT number
- NCT06837623
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 75
- From 1 Jul 2024 to the primary completion date, 22 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of strong CYP3A4 or P-glycoprotein inhibitors.
Other illness
- 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.
- Severe liver disease includes Child-Pugh class B or C, cirrhosis, or chronic active hepatitis.
- Established diagnosis of pericardial disease, myocarditis, hypertrophic cardiomyopathy, and cardiac amyloidosis
- Significant valvular heart disease.
Lab values
- Estimated glomerular filtration rate (eGFR) \<35 mL/min/1.73 m².
Other
- Presence of blood dyscrasias.
- Recent major cardiovascular events or procedures within the last 3 months.
- Lack of informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cairo University - Kasr Al-Ainy Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.