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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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
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