NCT01005303已完成2 期
A Trial of Micronutrient Supplementation in Patients With Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Left Ventricular Ejection Fraction
研究概览
简要总结
There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association Class II and III
- •Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)
- •Stable for a period of at least 6 weeks
- •Left ventricular ejection fraction less than or equal to 45%
排除标准
- •History of significant alcohol ingestion (more than 40 units per week)
- •Severe renal dysfunction (GFR less than 30ml/min)
- •Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)
- •Atrial fibrillation (in the absence of a pacemaker)
- •Frequent ventricular ectopics
- •On waiting list for cardiac transplantation
- •Uncontrolled diabetes mellitus
- •Inability to give informed consent
- •Estimated life span less than 12 months
- •Already taking a multivitamin/mineral supplement
- •Already taking a vitamin-D containing fish oil
- •Woman of child-bearing potential
- •History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Micronutrient
Active Comparator
干预措施: Forceval plus 50 micrograms Vitamin D3 (Drug)
结局指标
主要结局
Left Ventricular Ejection Fraction
时间窗: Baseline, and 12 months
次要结局
- Serum Interleukin-6 (IL-6) Concentration(Baseline, and 12 months)
- Serum C-reactive Protein (CRP) Concentration(Baseline, and 12 months)
- Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration(Baseline, and 12 months)
- Serum Interleukin-10 (IL-10) Concentration(Baseline, and 12 months)
- Six Minute Walk Test Distance(Baseline, and 12 months)
- Quality of Life Questionnaire Score(Baseline, and 12 months)
- Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration(Baseline, and 12 months)
- Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration(Baseline, and 12 months)
研究者
Pascal McKeown
Principal Investigator
Belfast Health and Social Care Trust
研究点 (1)
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