Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The change of valve calcification score on CT scan from baseline to 1 year of treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Sevelamer Treatment
Sevelamer 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.
干预措施: Sevelamer (Drug)
Calcium Carbonate Treatment
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.
干预措施: Calcium carbonate (Drug)
结局指标
主要结局
The change of valve calcification score on CT scan from baseline to 1 year of treatment.
时间窗: from baseline to 1 year of treatment
The change of valve calcification score on CT scan from baseline to 1 year of treatment.
次要结局
- major cardiovascular events(from baseline to 1 year of treatment)