Trials / Not Yet Recruiting
Not Yet RecruitingNCT06604611
Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation
Efficacy and Safety of Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Dongying Zhang · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.
Detailed description
HFpEF is a disease with complex pathophysiological mechanisms, and inflammation has been found to be strongly associated with the onset and progression of HFpEF. Anti-inflammatory treatments begin to cut a striking figure in cardiovascular disease therapy. The LoDoCo2 trial showed a significant prognostic improvement of colchicine in patients with chronic coronary artery disease, and the latest COLICA trial, showed that 8 weeks of colchicine treatment significantly reduced levels of circulating inflammatory markers in patients with decompensated heart failure without serious adverse effects. However, at present, the efficacy and safety of colchicine for the treatment of HFpEF remains unclear. The CHIPS trial is a multi-center, randomized, open-label clinical trial. The aim of the study is to evaluate the efficacy and safety of colchicine in patients with heart failure with preserved ejection fraction and inflammation. The investigators proposed to assess changes in KCCQ scores, NT-proBNP levels, echocardiography and plasma inflammatory marker levels in HFpEF patients treated with or without colchicine to evaluate the efficacy of colchicine in HFpEF treatment.
Conditions
- Heart Failure
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- Chronic Inflammation
- Inflammation
- Colchicine
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Colchicine 0.5 MG Oral Tablet Once Daily | The intervention in this study is colchicine, patients randomized to the experimental group will be given oral colchicine 5mg once a day in 12 weeks. |
Timeline
- Start date
- 2024-10-31
- Primary completion
- 2025-12-31
- Completion
- 2026-03-31
- First posted
- 2024-09-19
- Last updated
- 2024-09-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06604611. Inclusion in this directory is not an endorsement.