A Phase 4 interventional study of Colchicine 0.5 MG Oral Tablet Once Daily in Heart Failure, Heart Failure with Preserved Ejection Fraction (HFPEF) and Chronic Inflammation, sponsored by Dongying Zhang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Dongying Zhang · Phase 4, Interventional, and Treatment
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.
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.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 3,737 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Dongying Zhang is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group is intended to include 100 patients, all of the patients will be given 5mg of once-daily the colchicine treatment on top of the SGLT2i treatment
Drug: Colchicine 0.5 MG Oral Tablet Once Daily
The group is intended to include 100 patients, all of the patients will be given standard SGLT2i treatment
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.
Change in KCCQ-CS scores
Patients were assessed for symptom improvement by Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS)
Time frame: Up to 12 weeks
Change in 6-MWD
Improvement in patients exercise capacity assessed by 6-minuet walk distance
Time frame: Up to 12 weeks
Change in serum CRP levels
Change in serum C-reactive protein levels
Time frame: Up to 12 weeks
Change in serum NT-proBNP levels
Change in serum N-terminal pro-B-type natriuretic peptide levels
Time frame: Up to 12 weeks
Change in serum IL-1β levels
Change in serum interleukin-1β levels
Time frame: Up to 12 weeks
Change in serum IL-6 levels
Change in serum interleukin-6 levels
Time frame: Up to 12 weeks
Change in serum TNF-α levels
Change in serum tumor necrosis factor-α levels
Time frame: Up to 12 weeks
Change in cardiac structure
Left ventricular mass index (LVMI) measured by echocardiography
Time frame: Up to 12 weeks
Change in cardiac structure
Left atrial volume index (LAVI) measured by echocardiography
Time frame: Up to 12 weeks
Change in cardiac structure
Left ventricular end-diastolic diameter (LVEDD) measured by echocardiography
Time frame: Up to 12 weeks
Change in cardiac function
Tricuspid annular plane systolic excursion (TAPSE) measured by echocardiography
Time frame: Up to 12 weeks
Change in cardiac function
Right ventricular ejection fraction (RVEF) measured by echocardiography
Time frame: Up to 12 weeks
Change in cardiac function
Peak mitral inflow velocity and peak diastolic mitral annulus velocity measured by echocardiography
Time frame: Up to 12 weeks
Change in cardiac function
Early diastolic mitral annular tissue velocity (e') measured by echocardiography
Time frame: Up to 12 weeks
Worsening heart failure events
Time to first worsening heart failure events, including hospitalization due to heart failure or intravenous diuretic therapy
Time frame: Up to 12 weeks
Plan to share: No — The next study will be conducted at the end of this study, so the data cannot be shared.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Dongying Zhang