EUCTR2014-004592-23-IT进行中（未招募）1 期
Phase IV randomized, double blind, placebo-controlled study: role of hypovitaminosis D in heart failure and possible advantages of cholecalciferol (Vit D) administration - DLIFE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients who belong to the Service of Cardiology at Fondazione Toscana G. Monasterio
- •- Diagnosis of heart failure (NYHA class II-III)
- •- Optimized heart failure therapy according to clinical practice
- •- Medical conditions stable without change of heart medicine for at least 3 months
- •- Capacity / ability to perform the CPET
- •- Age> 18 years
- •- Sex female and male
- •- Signing of the informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Primary or secondary to kidney failure Hyperparathyroidism
- •- Phospho-calcic metabolism alterations/diseases
- •- History of pulmonary embolism
- •- Moderate-to-severe aortic and mitral stenosis
- •- Pericardial disease
- •- Severe obstructive lung disease
- •- Exercise-induced angina and significant ECG alterations
- •- Incapacity
- •- Pregnancy, lactation
- •- Cholecalciferol or expients intolerance
- •- Hypercalcemia/hypercalciuria
- •- Kidney stones (nephrolithiasis/nephrocalcinosis)
- •- Chronic kidney failure
- •- Current therapy, or place within three months prior to the study, along with other vitamin D analogs
- •- Use of anticonvulsants or barbiturates.
研究者
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