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更新于：2025-05-07

Cardiac valve calcification

心脏瓣膜钙化

更新于：2025-05-07

基本信息

别名

Calcifications of the cardiac valves、Cardiac valve calcification

简介

Abnormal calcification of a cardiac valve. [https://orcid.org/0000-0002-0736-9199]

关联

项与心脏瓣膜钙化相关的临床试验

NCT06952374

/ RecruitingN/AIIT

Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study

Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality.
Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated.
SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.

开始日期2025-03-08

申办/合作机构

沛嘉医疗科技（苏州）有限公司

NCT06660524

/ Recruiting临床4期IIT

Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.

The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are:
* Does Sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months?
* What are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? Researchers will compare Sevelamer to calcium carbonate to see if Sevelamer is more effective in reducing heart valve calcification.
Participants will:
* Take Sevelamer or calcium carbonate daily for 12 months.
* Undergo echocardiography and CT scans at baseline and after 12 months to assess heart valve calcification.
* Attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.

开始日期2024-03-01

申办/合作机构

国家心血管病中心

NCT04429035

/ Unknown statusN/AIIT

Inhibition of Aortic Valve Calcification Through the Carboxylation Mechanism of Matrix Gla Protein (MGP), Following Administration of Vitamin K2 (Menaquinone-7). Correlation With Mitral Annulus and Ascending Aorta Calcification.

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age < 50 y.o,prosthetic valves,Aortic Valve area (AVA) < 1cm2 ,Vmax > 4 m/s

开始日期2019-09-23

申办/合作机构

National & Kapodistrian University of Athens

100 项与心脏瓣膜钙化相关的临床结果

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100 项与心脏瓣膜钙化相关的转化医学

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0 项与心脏瓣膜钙化相关的专利（医药）

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项与心脏瓣膜钙化相关的文献（医药）

2025-12-31·Renal Failure

Development and external validation of a machine learning model for cardiac valve calcification early screening in dialysis patients: a multicenter study

Article

作者: Wang, Yao ; Wang, Xiaoxu ; Wu, Qianqian ; Shi, Wen ; Zheng, Jing ; Zhang, Aiqing ; Peng, Siqi ; Cao, Jingyuan ; Li, Yinfang ; Cao, Zixin ; Li, Min ; Fang, Yaping ; Li, Yunuo ; Zhang, Xiaoliang ; Wang, Bin ; Yang, Junlan

BACKGROUNDCardiac valve calcification (CVC) is common in dialysis patients and associated with increased cardiovascular risk. However, early screening has been limited by cost concerns. This study aimed to develop and validate a machine learning model to enhance early detection of CVC.METHODSData were collected at four centers between 2020 and 2023, including 852 dialysis patients in the development dataset and 661 in the external validation dataset. Predictive factors were selected using LASSO regression combined with univariate and multivariate analyses. Machine learning models including CatBoost, XGBoost, decision tree, support vector machine, random forest, and logistic regression were used to develop the CVC risk model. Model performance was evaluated in both validation sets. Risk thresholds were defined using the Youden index and validated in the external dataset.RESULTSIn the development dataset, 32.9% of patients were diagnosed with CVC. Age, dialysis duration, alkaline phosphatase, apolipoprotein A1, and intact parathyroid hormone were selected to construct the CVC risk prediction model. CatBoost exhibited the best performance in the training dataset. The logistic regression model demonstrated the best predictive performance in both internal and external validation sets, with AUROCs of 0.806 (95% CI 0.750-0.863) and 0.757 (95% CI 0.720-0.793), respectively. Calibration curves and decision curves confirmed its predictive accuracy and clinical applicability. The logistic regression model was selected as the optimal model and achieved excellent risk stratification in CVC risk prediction.CONCLUSIONThe predictive model effectively identifies CVC risk in dialysis patients and offers a robust tool for early detection and improved management.

2025-04-01·Cardiology Research

Advances in Pathophysiological Mechanisms of Degenerative Aortic Valve Disease

Review

作者: Yu, Ya Lu ; Jiang, Qin

Degenerative aortic valve disease (DAVD) represents the most prevalent valvular ailment among the elderly population, which significantly impacts their physical well-being and potentially poses a lethal risk. Currently, the underlying mechanisms of DAVD remain incompletely understood. While the progression of this disease has traditionally been attributed to degenerative processes associated with aging, numerous recent studies have revealed that heart valve calcification may represent a response of valve tissue to a specific initiating factor, involving the interaction of various genes and signaling pathways. This calcification process is further influenced by a range of factors, including genetic predispositions, environmental exposures, metabolic factors, and hemodynamic considerations. Based on the identification of its biomarkers, potential innovative therapeutic targets are proposed for the treatment of this complex condition. The present article primarily delves into the underlying pathophysiological mechanisms and advancements in diagnostic and therapeutic modalities pertaining to this malady.

2025-04-01·Open Medicine

The effect of ambulatory blood pressure load on mitral regurgitation in continuous ambulatory peritoneal dialysis patients

Article

作者: Li, Qingyun ; Zhu, Weiping ; Chen, Bairong ; Zhong, Xinqiang ; Cui, Tongxia

AbstractBackgroundHypertension is a risk factor for cardiovascular disease. The present study aimed to explore the impact of ambulatory blood pressure load (BPL) on mitral regurgitation (MR) in continuous ambulatory peritoneal dialysis (CAPD) patients.MethodsA total of 215 CAPD patients hospitalized in the Department of Nephrology at the Fifth Affiliated Hospital of Sun Yat-sen University between November 2017 and June 2022 were included in the study. All subjects underwent 24-h ambulatory BP monitoring and an echocardiography examination. BPL and MR area (MRA) were calculated. Subjects were divided into high regurgitation group and non-high regurgitation group. General data were also collected. The effect of ambulatory BPL on MR in CAPD patients was analyzed using multiple linear regression.ResultsBaseline data comparison revealed statistically significant differences in hemoglobin, serum β2-microglobulin, NT-proBNP, left atrial diameter (LAD), left ventricular end-diastolic diameter (LVDD), LV ejection fraction (LVEF), LV fractional shortening (LVFS), and mitral valve calcification between the high and non-high regurgitation groups (P < 0.05). There was no statistically significant difference in other clinical characteristics. Correlation analysis showed correlations between MRA and 24-h systolic BPL (24h-SBPL), 24-h diastolic BPL (24h-DBPL), daytime systolic BPL (D-SBPL), daytime DBPL (D-DBPL), nighttime systolic BPL (N-SBPL), nighttime DBPL (N-DBPL), hemoglobin level, NT-proBNP level, LAD, LVDD, LVEF, and LVFS. Multiple linear regression analysis revealed that the effects of 24h-DBPL and D-DBPL on MRA were statistically significantly different (P < 0.05).ConclusionsAmbulatory BPL, particularly 24h-DBPL and D-DBPL, significantly affected MR. Therefore, controlling BPL, especially DBPL, was essential for reducing the incidence of cardiovascular events and clinical mortality in CAPD patients.

项与心脏瓣膜钙化相关的新闻（医药）

2024-12-06

·复星医药

旁必福®商业上市一周年，持续守护中国慢性肾脏病（CKD）患者

回顾来时路 —— 点点滴滴，历历在目 2023 年 5 月 6 日，复星医药与安进合作获独家商业化授权的新型注射剂型拟钙剂依特卡肽（商品名：旁必福®）获国家药品监督管理局（NMPA）批准上市，用于治疗慢性肾脏病（CKD）血液透析的成人患者的继发性甲状旁腺功能亢进（SHPT）。开启了守护慢性肾脏病（CKD）患者的新征程。 2023年6 月 9 日，在中国医药教育协会临床肾脏病学专委会第二届年会上，旁必福®亮相会场。哈尔滨医科大学附属第一医院解汝娟教授强调拟钙剂在CKD-MBD综合管理中的重要价值，东南大学中大医院张晓良教授分享依特卡肽多维度获益，其在降PTH、提升达标率、心血管获益、降低骨折风险及提高患者依从性等方面表现出色，为血液透析伴SHPT患者提供了新选择。 2023年7 月 5 - 8日，中华医学会肾脏病学分会 2023 年血液净化论坛上，中南大学附属湘雅二医院的刘虹教授围绕旁必福®的作用机制、临床应用研究进行分享，让参会医生对于旁必福®临床研究成果有了初步了解。大会期间，复星医药还邀请了参与旁必福®国际多中心III期临床研究的专家开展了咨询会，就旁必福®临床研究结果和该产品的临床应用策略进行了深入的讨论。 2023年11 月 5 日第六届进博会，复星医药携旁必福®展示创新成果，体现开放创新理念。 2023年12 月 8 日，在中华医学会肾脏病学分会年会上，旁必福®全国上市会盛大开幕，标志其正式在中国商业上市，开启了造福患者的新篇章。图1 旁必福®上市会启动 2024 年1 月 5 日，随着旁必福®首张处方在中日友好医院落地，我国 SHPT 治疗进入新阶段。此后，复星医药携旁必福®积极参与多项学术交流，并在全国各地参与举办了近40场 CKD-MBD 规范化诊疗巡讲系列活动，持续传递治疗新理念。 2024年10月，《拟钙剂治疗维持性血液透析患者继发性甲状旁腺功能亢进症的中国专家共识(2024版)》在《中国血液净化》杂志上发表，依特卡肽被推荐为一线用药。 2024年11月7日，旁必福®再次亮相进博会。“肾”生不息——关爱肾病透析患者倡议行动在复星医药展台召开。上海长征医院梅长林教授、上海市第一人民医院袁伟杰教授、复星医药国内营销平台联席总裁刘焰女士及非肿瘤市场部副总经理来晶先生亲临现场，多位肾病领域专家通过录制视频共同和现场嘉宾发出倡议：关爱肾病透析患者，从你我做起，一起为他们的健康和未来加油！图2 进博会现场共同倡议合影回望商业上市一年以来，旁必福®已经辐射全国500多家血透中心，惠及1000多位患者，得到了多位国内肾病治疗领域专家的认可与支持。旁必福® —— 实现更高的iPTH达标率 1. 拟钙剂是血液透析患者SHPT治疗的一线药物之一1。依特卡肽降iPTH疗效显著，是现有SHPT治疗药物中，使iPTH达标可能性最高的药物2。图3 网状meta分析中，不同治疗方案PTH达标概率 2. 心血管疾病（CVD）是血液透析患者的主要死亡原因，血液透析患者心血管死亡发生率是普通人群的10-30倍3。诸多研究显示依特卡肽可以给患者带来潜在心血管获益。 1）依特卡肽较维生素D类似物延缓左室肥厚进展、改善左房功能 ETECAR-HD研究4，是一项随机、对照、单盲试验，纳入62例SHPT合并左室肥厚（LVH）的维持性血液透析患者，比较了依特卡肽与阿法骨化醇对LVH进展的影响。该研究显示，随访12个月后，依特卡肽组左心室质量指数（LVMI）较基线轻微逆转，而阿法骨化醇组患者LVMI显著进展（图4）。图4 ITT人群和符合方案人群，依特卡肽组和阿法骨化醇组LVMI较基线变化该研究的事后分析显示5，依特卡肽组左房容积指数（LAVI）较基线轻微逆转，而阿法骨化醇组患者LAVI显著进展（组间差异5.8 mL/m2，95%CI 0.36-11，p=0.037）（图5），提示依特卡肽在延缓左房容积指数进展上优于维生素D类似物。图5 依特卡肽组和阿法骨化醇组LAVI较基线变化 2）依特卡肽协同降钙、磷，延缓血管钙化进展透析患者血管钙化是另一个重要的心血管风险因素。我国CDCS研究6显示透析患者血管钙化患病率高达77.1%，其中冠状动脉钙化（CAC）、腹主动脉钙化（AAC）、心脏瓣膜钙化（CVC）的患病率分别为68.0%、46.2%和29.0%。透析患者血管钙化不仅患病率高，且进展比例高。随访4年，86.5%的患者出现血管钙化进展，其中不同部位钙化进展的比例为CAC（69.6%）、AAC（72.4%）和CVC（33.4%）。拟钙剂通过协同降低血钙、血磷水平，减轻体内钙负荷，可以延缓血管钙化进展。依特卡肽对比马沙骨化醇治疗SHPT患者研究显示，在合并SHPT的血液透析患者中，依特卡肽能够更有效地提高T50值（T50越低，钙化倾向越高）7。一项历史队列研究8在倾向性评分匹配后，纳入36例CAC评分≥100的血液透析SHPT患者。随访1年后，依特卡肽治疗组CAC评分较基线仅增加4%，而非拟钙剂治疗组CAC评分增加18%（p=0.0284）（图6）。图6 使用依特卡肽治疗1年后Agatston CAC评分变化 3. 依特卡肽有助于改善血透SHPT患者骨密度，降低骨折风险 SHPT与骨质疏松和骨折存在相关性，接受血液透析治疗的肾衰竭患者发生骨折的风险会增加4倍以上。依特卡肽用于SHPT患者，同样可以降低骨折风险。一项纳入203例接受血液透析的SHPT患者的前瞻性队列研究9。患者分成两组，主要治疗组（71例）接受拟钙剂依特卡肽治疗，历史对照组（132例）为未接受拟钙剂治疗。主要终点为全因死亡、骨折发生率、甲状旁腺切除术和心血管死亡。图7 未经拟钙剂治疗的患者骨折发生率约是依特卡肽治疗组的3倍展望未来 —— 旁必福®将继续与医生共同守护CKD患者健康回顾旁必福®上市一周年，不断为患者带来新希望，在CKD SHPT治疗领域留下了坚实的足迹。未来，旁必福®将一如既往地与广大医疗工作者肩并肩、心连心，齐心协力，共同肩负起守护CKD患者健康的神圣使命，继续为患者带来希望！参考文献： 1、拟钙剂治疗MHD患者SHPT专家共识工作组,左力.拟钙剂治疗维持性血液透析患者继发性甲状旁腺功能亢进症的中国专家共识(2024版)[J].中国血液净化,2024,23(10):721-735. 2、 Suetonia C Palmer, et al. Am J Kidney Dis . 2020 Sep;76(3):321-330. 3、 Sarnak MJ, et al.Circulation. 2003, 108(17):2154-2169. 4、 Dörr K, et al. Circ Res. 2021, 128(11):1616-1625. 5、 Dörr K, et al. Cardiorenal Med. 2023, 13(1):332-341. 6、 Zhang H, et al.. JAMA Netw Open. 2023;6(5):e2310909. 7、Shoji T, et al. CJASN. 2021, 16(4):599-612. 8、 Toshiki Doi KM, et al. In: American Society of Nephrology. America; 2023. 9、 Dudar I, et al. Pol Merkur Lekarski. 2022 Oct 21;50(299):294-298. 仅供医疗卫生专业人士参考

临床3期