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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine Treatment Group | Experimental | 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 |
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| Control Group | No Intervention | The group is intended to include 100 patients, all of the patients will be given standard SGLT2i treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG Oral Tablet Once Daily | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KCCQ-CS scores | Patients were assessed for symptom improvement by Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) | Up to 12 weeks |
| Change in 6-MWD | Improvement in patients exercise capacity assessed by 6-minuet walk distance | Up to 12 weeks |
| Change in serum CRP levels | Change in serum C-reactive protein levels | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum NT-proBNP levels | Change in serum N-terminal pro-B-type natriuretic peptide levels | Up to 12 weeks |
| Change in serum IL-1β levels | Change in serum interleukin-1β levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junlong Chen, MD. | Contact | 86-15111871817 | junlongchen2024@163.com | |
| Lei Gao, MD. | Contact | 86-15123908507 | 653161583@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongying Zhang, MD. Ph.D. | First Affiliated Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35363499 | Background | Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. | |
| 32865380 |
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The next study will be conducted at the end of this study, so the data cannot be shared.
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Patients will be randomly 1:1 allocate into either a colchicine-treated group or a blank control group, and patients included in different centers will be uniformly randomized by the main centre.
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| Up to 12 weeks |
| Change in serum IL-6 levels | Change in serum interleukin-6 levels | Up to 12 weeks |
| Change in serum TNF-α levels | Change in serum tumor necrosis factor-α levels | Up to 12 weeks |
| Change in cardiac structure | Left ventricular mass index (LVMI) measured by echocardiography | Up to 12 weeks |
| Change in cardiac structure | Left atrial volume index (LAVI) measured by echocardiography | Up to 12 weeks |
| Change in cardiac structure | Left ventricular end-diastolic diameter (LVEDD) measured by echocardiography | Up to 12 weeks |
| Change in cardiac function | Tricuspid annular plane systolic excursion (TAPSE) measured by echocardiography | Up to 12 weeks |
| Change in cardiac function | Right ventricular ejection fraction (RVEF) measured by echocardiography | Up to 12 weeks |
| Change in cardiac function | Peak mitral inflow velocity and peak diastolic mitral annulus velocity measured by echocardiography | Up to 12 weeks |
| Change in cardiac function | Early diastolic mitral annular tissue velocity (e') measured by echocardiography | 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 | Up to 12 weeks |
| Result |
| Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31. |
| 39211951 | Result | Pascual-Figal D, Nunez J, Perez-Martinez MT, Gonzalez-Juanatey JR, Taibo-Urquia M, Llacer-Iborra P, Delgado J, Villar S, Mirabet S, Aimo A, Riquelme-Perez A, Anguita-Sanchez M, Martinez-Selles M, Noguera-Velasco JA, Ibanez B, Bayes-Genis A. Colchicine in acutely decompensated heart failure: the COLICA trial. Eur Heart J. 2024 Dec 1;45(45):4826-4836. doi: 10.1093/eurheartj/ehae538. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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