Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi
{"title":"低剂量秋水仙碱对主动脉瓣狭窄进展的影响：秋水仙碱与主动脉瓣狭窄炎症（CHIANTI）试验的基本原理、设计和基线特征","authors":"Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi","doi":"10.1016/j.ahj.2025.07.010","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Aortic valve stenosis (AS) is one of the most common valvular heart diseases worldwide. Its prevalence increases with age and is expected to rise further as the population ages. Untreated severe AS carries a 2-year mortality rate exceeding 50%. Furthermore, surveillance and management of AS impose a significant burden on healthcare systems. Therefore, effective pharmacological strategies are urgently needed to slow or halt the progression of AS.</p><p><strong>Rationale and design: </strong>Inflammation plays a central role in the pathogenesis of both atherosclerosis and AS. Anti-inflammatory therapy with low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, but its efficacy has not been tested in AS. Colchicine and Inflammation in Aortic Stenosis (CHIANTI) is an investigator-initiated, placebo-controlled, double-blind, multicenter, randomized trial involving 150 patients with moderate AS. After confirming tolerance during a two-week run-in phase, eligible participants underwent coronary computed tomography (CT) angiography, <sup>18</sup>F-sodium fluoride (<sup>18</sup>F-NaF) positron emission tomography (PET)-CT, and echocardiography. Thereafter, participants were randomized 1:1 to colchicine 0.5 mg once daily or a matching placebo. All baseline imaging is repeated after 24 months. The primary endpoint is the change in aortic valve calcium score on CT. Secondary endpoints are (1) the change in aortic valve <sup>18</sup>F-NaF uptake on PET-CT and corrected for target-to-background ratio, and (2) the change in peak aortic jet velocity on echocardiography.</p><p><strong>Conclusion: </strong>The CHIANTI trial evaluates whether anti-inflammatory therapy with low-dose colchicine can slow or halt the progression of moderate AS. If successful, it would offer the first effective pharmacological treatment for AS.</p><p><strong>Trial registration: </strong>Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"297-309"},"PeriodicalIF":3.5000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial.\",\"authors\":\"Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi\",\"doi\":\"10.1016/j.ahj.2025.07.010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Aortic valve stenosis (AS) is one of the most common valvular heart diseases worldwide. Its prevalence increases with age and is expected to rise further as the population ages. Untreated severe AS carries a 2-year mortality rate exceeding 50%. Furthermore, surveillance and management of AS impose a significant burden on healthcare systems. Therefore, effective pharmacological strategies are urgently needed to slow or halt the progression of AS.</p><p><strong>Rationale and design: </strong>Inflammation plays a central role in the pathogenesis of both atherosclerosis and AS. Anti-inflammatory therapy with low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, but its efficacy has not been tested in AS. Colchicine and Inflammation in Aortic Stenosis (CHIANTI) is an investigator-initiated, placebo-controlled, double-blind, multicenter, randomized trial involving 150 patients with moderate AS. After confirming tolerance during a two-week run-in phase, eligible participants underwent coronary computed tomography (CT) angiography, <sup>18</sup>F-sodium fluoride (<sup>18</sup>F-NaF) positron emission tomography (PET)-CT, and echocardiography. Thereafter, participants were randomized 1:1 to colchicine 0.5 mg once daily or a matching placebo. All baseline imaging is repeated after 24 months. The primary endpoint is the change in aortic valve calcium score on CT. Secondary endpoints are (1) the change in aortic valve <sup>18</sup>F-NaF uptake on PET-CT and corrected for target-to-background ratio, and (2) the change in peak aortic jet velocity on echocardiography.</p><p><strong>Conclusion: </strong>The CHIANTI trial evaluates whether anti-inflammatory therapy with low-dose colchicine can slow or halt the progression of moderate AS. If successful, it would offer the first effective pharmacological treatment for AS.</p><p><strong>Trial registration: </strong>Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.</p>\",\"PeriodicalId\":7868,\"journal\":{\"name\":\"American heart journal\",\"volume\":\" \",\"pages\":\"297-309\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American heart journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ahj.2025.07.010\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/12 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ahj.2025.07.010","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/12 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial.
Background: Aortic valve stenosis (AS) is one of the most common valvular heart diseases worldwide. Its prevalence increases with age and is expected to rise further as the population ages. Untreated severe AS carries a 2-year mortality rate exceeding 50%. Furthermore, surveillance and management of AS impose a significant burden on healthcare systems. Therefore, effective pharmacological strategies are urgently needed to slow or halt the progression of AS.
Rationale and design: Inflammation plays a central role in the pathogenesis of both atherosclerosis and AS. Anti-inflammatory therapy with low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, but its efficacy has not been tested in AS. Colchicine and Inflammation in Aortic Stenosis (CHIANTI) is an investigator-initiated, placebo-controlled, double-blind, multicenter, randomized trial involving 150 patients with moderate AS. After confirming tolerance during a two-week run-in phase, eligible participants underwent coronary computed tomography (CT) angiography, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET)-CT, and echocardiography. Thereafter, participants were randomized 1:1 to colchicine 0.5 mg once daily or a matching placebo. All baseline imaging is repeated after 24 months. The primary endpoint is the change in aortic valve calcium score on CT. Secondary endpoints are (1) the change in aortic valve 18F-NaF uptake on PET-CT and corrected for target-to-background ratio, and (2) the change in peak aortic jet velocity on echocardiography.
Conclusion: The CHIANTI trial evaluates whether anti-inflammatory therapy with low-dose colchicine can slow or halt the progression of moderate AS. If successful, it would offer the first effective pharmacological treatment for AS.
Trial registration: Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.
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The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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