Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604611
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIPS
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None