Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Sevelamer
  Sevelamer is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guidelines for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.
• Препарат Calcium carbonate
  Calcium carbonate is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.

Первичные конечные точки

• The change of valve calcification score on CT scan from baseline to 1 year of treatment. [Срок оценки: from baseline to 1 year of treatment]

Вторичные конечные точки (1)

• major cardiovascular events [Срок оценки: from baseline to 1 year of treatment]

Критерии участия

Критерии включения

• Age ≥ 50 years old.

• Degenerative valvular heart disease clearly diagnosed by ultrasound or clinical history with calcification manifestation (including no stenosis or insufficiency due to calcification, mild, moderate and severe stenosis and insufficiency caused by calcification).

• Glomerular filtration rate < 60 mL/min (CKD-EPI formula).

• Serum phosphorus > 1.45 mmol/L (4.5 mg/dl).

Критерии исключения

• Patients refuse to sign the informed consent form for the study.

• Non-degenerative valvular heart disease even if there is valvular calcification, such as rheumatic valvular heart disease, congenital valvular heart disease, etc.

• Valve lesions are evaluated by cardiac surgeons and have indications for surgical thoracotomy or interventional medical treatment and there are no surgical contraindications.

• Life expectancy less than 1 year. ⑤ Abnormal parathyroid function.

• Those with renal insufficiency who are planned to undergo dialysis treatment within half a year.

• Malignant tumor.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sci — Пекин

Публикации

• Doris MK, Jenkins W, Robson P, Pawade T, Andrews JP, Bing R, Cartlidge T, Shah A, Pickering A, Williams MC, Fayad ZA, White A, van Beek EJ, Newby DE, Dweck MR. Computed tomography aortic valve calcium scoring for the assessment of aortic stenosis progression. Heart. 2020 Dec;106(24):1906-1913. doi: 10.1136/heartjnl-2020-317125. Epub 2020 Oct 5. PMID 33020228
• Williams MC, Massera D, Moss AJ, Bing R, Bularga A, Adamson PD, Hunter A, Alam S, Shah ASV, Pawade T, Roditi G, van Beek EJR, Nicol ED, Newby DE, Dweck MR. Prevalence and clinical implications of valvular calcification on coronary computed tomography angiography. Eur Heart J Cardiovasc Imaging. 2021 Feb 22;22(3):262-270. doi: 10.1093/ehjci/jeaa263. PMID 33306104
• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632 PMID 34453165
• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006. PMID 19414839
• Meng Z, Li Z, Zhang E, Zhang L, Liu Q, Wu Y. Sevelamer Attenuates Bioprosthetic Heart Valve Calcification. Front Cardiovasc Med. 2021 Sep 29;8:740038. doi: 10.3389/fcvm.2021.740038. eCollection 2021. PMID 34660741
• Hoevelmann J, Mahfoud F, Lauder L, Scheller B, Bohm M, Ewen S. Valvular heart disease in patients with chronic kidney disease. Herz. 2021 Jun;46(3):228-233. doi: 10.1007/s00059-020-05011-0. Epub 2021 Jan 4. PMID 33394059
• Urena-Torres P, D'Marco L, Raggi P, Garcia-Moll X, Brandenburg V, Mazzaferro S, Lieber A, Guirado L, Bover J. Valvular heart disease and calcification in CKD: more common than appreciated. Nephrol Dial Transplant. 2020 Dec 4;35(12):2046-2053. doi: 10.1093/ndt/gfz133. PMID 31326992
• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available. PMID 30675420

Идентификаторы

NCT: NCT06660524 · 2023-GSP-GG-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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