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.
Left ventricular ejection fraction measured by echocardiography ≥ 50%
Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g/m2 in female and ≥115 g/m2 in male or 2)LAVI greater than 29ml/m2 in sinus rhythm or greater than 40ml/m2 in atrial fibrillation or 3)Average E/e' greater than 14 or 4)TR velocity greater than 2.8 m/s
Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg/ml in patients with sinus heart rate; ≥600 pg/ml in patients with atrial fibrillation
Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV
Received colchicine treatment within one month prior to randomization
Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months
eGFR less than 25 mL/min/1.73 m2
Liver function Child-Pugh class B or C
Parallel
Colchicine 0.5 MG Oral Tablet Once Daily
DrugThe 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)
Change in 6-MWD
Improvement in patients exercise capacity assessed by 6-minuet walk distance
Change in serum CRP levels
Change in serum C-reactive protein levels
Change in serum NT-proBNP levels
Change in serum N-terminal pro-B-type natriuretic peptide levels
Change in serum IL-1β levels
Change in serum interleukin-1β levels
Change in serum IL-6 levels
Change in serum interleukin-6 levels
Change in serum TNF-α levels
Change in serum tumor necrosis factor-α levels
Click on the lead sponsor to view all of their trials.
Dongying Zhang
Lead sponsor
Chongqing Medical University
Sponsor institution
National Natural Science Foundation of China
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
