Status:
NOT_YET_RECRUITING
Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation
Lead Sponsor:
Dongying Zhang
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Heart Failure
Heart Failure with Preserved Ejection Fraction (HFPEF)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients with CRP levels greater than 2mg/L
- Patient agrees to join and signs a written informed consent form
Exclusion
- 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
- Patient has a history of previous allergy to colchicine or dapagliflozin / empagliflozin
- Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease
- Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors
- Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures
- Pregnant or breastfeeding women
- The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician
- Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6
- Patient with combined active solid tumor or hematological malignancy
- Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD
- Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10\*109/L)
- Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06604611
Start Date
October 31 2024
End Date
March 31 2026
Last Update
September 19 2024
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000